| Job List |
| Job ID: |
GT-03318-2 - Clinical Trial Manager III |
| Description: |
Summary of Position:
The Clinical Trial Manager III is accountable
for the day-to-day operations of 1-4 clinical trials commensurate
with complexity, including trial start-up, conduct, and close-out
activities.
Job
Duties/Responsibilities:
- Performs job
duties independently with minimal guidance from the Clinical Program
Manager.
- Leads the Protocol Execution
Team (PET) to ensure that trial timelines, costs, and quality
metrics are met
- Serves as primary contact
for functional area representatives in managing protocol execution
- Ensures accuracy and timeliness of vendor
and site payments
- Oversees forecasting of
clinical/non-clinical supplies
-
Establishes study milestones and ensures accurate tracking and
reporting of study metrics
- Manages
trial-specific Genentech collaborations with other research entities
(e.g., Cooperative Group Trials, Investigator Sponsored Trials,
Global Partner Trials)
- Performs ongoing
vendor management (e.g., CROs, IVRS, Reading Centers), including
independent negotiation of vendors scope of works and budgets,
performance management, and issue resolution
- Creates and manages clinical trial budgets
and staffing/resourcing plans
- Provides
study-specific direction and mentoring to Clinical Site Managers,
Clinical Trial Associates and support staff as appropriate
- Provides support and mentoring to other
Clinical Trial Managers
- Ensures trial
adherence to ICH/GCP/local regulations
-
Participates in clinical operations initiatives and programs as
assigned
Competencies Identified for Success:
- Highly developed leadership skills to build
and directs the Protocol Execution Team to ensure that timeline,
cost and quality metrics are met
-
Effective written and verbal communication skills
- Extensive experience developing trial plans
including site monitoring strategies, risk mitigation strategies,
trial budgets, site selection, and clinical supplies management
- Extensive clinical research knowledge and
cross-functional understanding of clinical trial methodology
- Collaborates effectively with the Clinical
Operations study team, cross-functional team members, and external
partners
Education, Experience, and Other Requirements:
- Bachelor's Degree with a minimum of eight
years of clinical research experience
-
Therapeutic knowledge preferred
- Knowledge
of GCP and ICH
- Proficient computer skills
- Travel may be required |
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Salary: OPEN, Job Type: Permanent, Total Exp: 7-10 Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
LP-05028-1 - CRA |
| Description: |
RESPONSIBILITIES:
-
Assist with Administration of clinical research projects: recruiting
investigators, collecting investigator documentation, site
management, "clinical contact," and preparing status reports.
- Initiate, monitor and close-out clinical
investigative sites under supervision from Project Managers and
Project Directors.
- Provide ongoing
assistance and education of investigational sites in clinical
research.
- Update, track and maintain
study specific trial management tools/system.
- Monitor Case Report Forms (CRF) for missing
implausible data. Assist sites with maintaining Good Clinical
Practices (GCP).
- May report, write
narratives and follow-up on reported serious adverse experiences.
- Assist with generation and reconciliation
of queries to investigation sites to resolve problem data.
- Assist and manage project budget and
investigator site budget, attend and project team meetings, plan and
attend investigator meetings, and communicate with clients.
- Generate and track drug shipments and
storage.
- Provide coverage to clinical
contact telephone lines.
- Travel as
necessary, consistent with project needs.
Job Requirements:
BS degree in Clinical or Biological Science.
1 - 2 years experience in Drug Development,
Regulatory Affairs.
Previous CRA
experience.
50% travel required.
MS Word, Excel, Medical/Regulatory Terminology.
Outstanding communication skills.
Dialysis, rheumatology, oncology, cardiology or
GI experience preferred. |
| |
Salary: OPEN, Job Type: Permanent,Contract, Total Exp: 2+ yrs,
Start Date: ASAP,
Location: Philadelphia Area |
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| Job ID: |
PC-07186-1 - CRA I/II |
| Description: |
BS/BA or RN plus 2+ years on-site monitoring
for a pharma/biotech company or CRO with a total of 4+ years
experience in clinical research, drug development, data management,
or other healthcare environment.
Therapeutic preference is Neuroscience, however
all therapeutic areas will be considered.
Abliity and
willingness to travel up to 80% of the time. |
| |
Salary: 40-65K, Job Type: Permanent, Total Exp: 6 months- 2 Yrs, Location: Princeton, NJ, Blue Bell,RTP,San Diego,
Boston |
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| Job ID: |
PN-11307-1 - CRA I/II |
| Description: |
Our client, a growing CRO is looking for
individuals with experience monitoring oncology studies. Several
positions exist, depending upon your experience and situation.
This is a CRO that cares for and rewards their
clinical monitoring talent. Some of the extras they provide their
CRAs include:
• One airline club memberships
to all CRAs who travel
• Focus on limited
number of Protocols (typically 2-3)
•
Light-weight laptops
• Excellent time
management system and superior connectivity
• Excellent career path opportunities (PM)
whether office or home-office based
•
Experienced management team. Regional CRAs have dedicated line
managers
• Team environment, including
annual meetings
• Company pays for 1
professional membership/year i.e. SOCRA, ACRP
• Reimbursement for professional exams and
certifications
• Quick turnaround on expense
reimbursement
• Car Allowance for certain
levels
Position can be office based (San
Diego, CA) or home-based (must reside within the Pacific Time Zone:
e.g. CA, AZ, NV, or Canada.)
CRA I/II:
Responsibilities: On-site monitoring,
protocol/CRF development, investigator recruitment, in-house review
of clinical data, generation of project-management reports, and
assisting in the preparation of clinical study reports. Travel will
average 50%.
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 2+ Years,
Location: Westcoast
|
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| Job ID: |
TB-01158-4 - CRA II/Lead CRA |
| Description: |
CLINICAL RESEARCH ASSOCIATE II
This is a lead position. The Clinical Research
Associate II manages the implementation of study protocols at
research sites. Responsibilities include but are not limited to:
serving as lead CRA for clinical studies; performing monitoring
visits including site qualification, initiation, monitoring and
closeout visits; developing monitoring plan; maintaining contact
with study sites, report preparation and communications
documentation; conducting training; preparing for and participating
in Sponsor and FDA audits; managing clinical project assistants and
associates.
Required qualifications: BA/BS degree or
equivalent combination of education and experience in a medical or
scientific discipline; minimum 1 year monitoring experience;
significant technical, medical or industry experience in a clinical
research setting; strong understanding of Medical Terminology,
Physiology, and Pathophysiology; working knowledge of Good Clinical
Practices; strong organizational skills; the ability to multi-task
and work effectively in a fast-paced environment; strong written and
verbal communication and diplomacy skills; professional demeanor and
appearance; ability to travel 30%.
Preferred qualifications: BS in scientific
discipline; 2+ years experience in a CRO.
|
| |
Salary: 70-80k, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Southborough, MA |
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| Job ID: |
OS-08307-1 - CRA III -Device |
| Description: |
Job Description:
The
Clinical Research Associate III position oversees clinical trial
administration and monitoring, including the supervision of other
CRAs. The CRA ensures clinical trials comply with protocols and
overall clinical objectives and that these trials adhere to good
clinical practices and regulatory requirements. The CRA will oversee
the creation of the clinical department SOPs, revise the clinical
record keeping practices as needed to comply with regulatory
requirements. The CRA will assist with the analysis and evaluation
of clinical data as needed and will assist in the development of the
ability to conduct animal trials using good laboratory practices,
including the development of appropriate SOPs and record keeping.
Designs and develops
clinical trial protocols and case report forms
Performs pre-study, site initiation, monitoring
and close out activities for clinical studies
Prepares investigational site training
presentation and materials
Contributes to
database development, and completion of DCFs
Generates reports following site visits
Works with Regulatory Affairs to accomplish
clinical objectives
Oversee the collection,
monitoring and tracking of essential documents from both OptiScan
Biomedical and the investigational sites and the creation and
maintenance of regulatory and study binders, correspondence files,
etc.
Generates all clinical SOPs in support
of the clinical department
May involve
travel approximately 30%
Assist in
developing the SOPs needed to run animal studies under GLP.
Education:
B.S. in science, nursing or related field
M.S. preferred
Qualifications:
5 – 8
years experience in clinical research associate
Demonstrated proficiency managing and
monitoring clinical trial activities from initiation to close-out
Complete knowledge of GCP and GLP
Ability to author SOPs in accordance with
company quality standards and GCP, GLP
Medical device experience preferred
Clinical lab experience an additional
benefit
|
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Salary: 80-90k, Job Type: Permanent, Total Exp: 5-8 Years, Start Date: ASAP,
Location: Sf Bay
Area |
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| Job ID: |
RG-11267-2 - CRA in-house Low Travel |
| Description: |
Job Title: Clinical Trial Associate Manager (
this is an in-house CRA position)
Therapeutic areas: oncology, opthamology, and
inflammatory diseases
Summary: Coordinates and implements clinical
research projects and is involved with writing protocols and
identifying, qualifying, and training clinical sites to conduct
clinical trials. Oversees the collection of data to ensure
compliance with protocol and the clinical research project
objectives as well as FDA / ICH / GCP regulations and guidelines.
Must be able to travel to field sites to assist with clinical
studies.
Essential
Duties and Responsibilities include, but are not limited to the
following:
-Interacts regularly with CRO,
central laboratory, and IVRS systems.
-Follows established clinical study standards
and procedures to plan and conduct clinical research studies.
-Assists with/and/or may play a lead role in
the development of procedures and tools for data collection.
-Work is assigned through general instructions
given for routine work; more detailed instruction is provided for
new projects.
-Applies knowledge of company
policies and standard practices to resolve problems.
-Analyzes issues and uses judgment to make
decisions.
-Escalates non-standard problems
or issues as may be required.
-Compiles and
maintains regular status reports of study progress.
-Assists with and/or may play a lead role in
the development of study documents including protocols, informed
consent forms, and procedure manuals.
-Maintains open communication channels with
study sites and members of the study team.
Knowledge and
Specialized Skills:
Analytical problem
solving experience. Working knowledge of the clinical research
process and regulations/guidelines. Can effectively communicate in
large or small group settings. Understands
current and possible future business trends and information.
Clinical Research knowledge is essential. Can
effectively write so needed messages are clear
and understood.
Education and Experience:
A Bachelor's degree (BS) from an accredited
college or university plus four (4) or more years of industry
related experience is required. A Master's degree (MS) and two (2)
or more years of experience is also accepted. Some CRA positions may
require additional training within the healthcare field.
Low travel: up to 25%.
Relocation plan available.
|
| |
Salary: 65-95K, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
TB-01158-5 - Regional CRA I |
| Description: |
REGIONAL CLINICAL RESEARCH ASSOCIATE I
Under general supervision, the Regional
Clinical Research Associate I manages the implementation and conduct
of study protocols at research sites. Responsibilities include but
are not limited to: performing monitoring visits including site
qualification, initiation, periodic monitoring and close-out visits;
maintaining regular contact with study site to ensure protocol/GCP
compliance; participating in Investigator meetings and other study
training meetings as required; preparing for and participating in
Sponsor and FDA audits; preparing reports and communications
documentation.
Required qualifications: Associate’s degree or
equivalent combination of education and experience in a medical or
scientific discipline; significant technical, medical, or industry
experience in a clinical research setting; strong understanding of
Medical Terminology, Physiology, and Pathophysiology; basic
understanding of Good Clinical Practices; strong organizational
skills; the ability to multi-task; the ability to manage multiple
study sites and multiple studies; strong written and verbal
communication and diplomacy skills; professional demeanor and
appearance; ability to travel 75-85%.
Preferred qualifications: BS in scientific
discipline; 2+ years experience including at least 1 year of field
monitoring within a CRO or other clinical research setting. Oncology
experience required
|
| |
Salary: 80-90k, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Westcoast or CA |
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| Job ID: |
CIR-01168-1 - Regional CRA |
| Description: |
The Regional CRA manages the implementation of
study protocols at research sites. Responsibilities include but are
not limited to: serving as a CRA for clinical studies; performing
monitoring visits including site qualification, initiation,
monitoring and closeout visits; developing monitoring plan;
maintaining contact with study sites, report preparation and
communications documentation; conducting training; preparing for and
participating in Sponsor and FDA audits; managing clinical project
assistants and associates.
Required qualifications: BA/BS degree or
equivalent combination of education and experience in a medical or
scientific discipline; minimum 1 year regional monitoring
experience; significant technical, medical or industry experience in
a clinical research setting; strong understanding of Medical
Terminology, Physiology, and Pathophysiology; working knowledge of
Good Clinical Practices; strong organizational skills; the ability
to multi-task and work effectively in a fast-paced environment;
strong written and verbal communication and diplomacy skills;
professional demeanor and appearance; ability to travel.
Preferred
qualifications: BS in scientific discipline; 2+ years experience in
a CRO.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2-4 Yrs,
Location: Most USA
locations |
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| Job ID: |
CLM-09277-1 - Regional CRA |
| Description: |
my client is a highly respected leader in the
Pharmaceutical, Biotechnology and Medical Device Industries,
provides clinical research consulting and management services. We
are a rapidly growing CRO, offering competitive compensation and
excellent benefits, in a fast-paced team oriented environment.
Purpose of
Position:
We currently have multiple
regional Clinical Research Associate (CRA) positions available
throughout Canada. As a CRA, the primary focus of this position is
on the implementation of clinical studies for our clients,
specifically study monitoring responsibilities.
Requirements and
Responsibilities:
Candidates will monitor
clinical sites and insure that all documentation is maintained and
in compliance with FDA/ICH guidelines.
Education & Experience:
We require RN/Bachelor's degree in the
biological sciences or related field, plus 2 years clinical research
experience. Must have strong interpersonal and communication skills
as well as excellent problem-solving ability.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Canada |
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| Job ID: |
CLM-09277-3 - Regional CRA |
| Description: |
my client is a highly respected leader in the
Pharmaceutical, Biotechnology and Medical Device Industries,
provides clinical research consulting and management services. We
are a rapidly growing CRO, offering competitive compensation and
excellent benefits, in a fast-paced team oriented environment.
Purpose of
Position:
We currently have multiple
regional Clinical Research Associate (CRA) positions available
throughout Canada. As a CRA, the primary focus of this position is
on the implementation of clinical studies for our clients,
specifically study monitoring responsibilities.
Requirements and
Responsibilities:
Candidates will monitor
clinical sites and insure that all documentation is maintained and
in compliance with FDA/ICH guidelines.
Education & Experience:
We require RN/Bachelor's degree in the
biological sciences or related field, plus 2 years clinical research
experience. Must have strong interpersonal and communication skills
as well as excellent problem-solving ability.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: All US Locations |
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| Job ID: |
DS-01318-1 - Regional CRA |
| Description: |
This Contract Services Organization is a global
CRO headquartered in Rockville, MD. They are focused on
cardiovascular, renal, and metabolic clinical development programs
for the pharmaceutical and biotech industry. This company offers
project and data management, clinical site monitoring,
biostatistical analysis, and regulatory support for companies
involved in Phase II through Phase IV drug studies. They are a
growing company with a good reputation in Clinicals.
They are currently
seeking a Clinical Research Associate for the Midwest and a Clinical
Research Associate for the East Coast.
Position Description:
The Clinical Research Associate supports the
clinical development process for investigational drugs; performs
routine monitoring visits to ensure compliance with ICH-GCP
guidelines, local regulations, and corporate SOPs and
project-specific instructions.
Responsibilities Include:
Develops a detailed working knowledge of all
assigned protocols; attends project-specific training as
required.
Manages sites according to
project-specific Monitoring Guidelines and instructions from the
Lead CRA.
Schedules monitoring visits with
all sites as required for the project and as outlined by the Lead
CRA, while working within budgetary guidelines.
Communicates expectations for and results from
the monitoring visits with site personnel, the in-house project
team, and the sponsor and writes visit reports in the timeframe
required by the project.
Reviews available
in-house data relating to recruitment and CRF status, as well as
preliminary data from fax data systems or remote data entry systems,
prior to visiting the site for each monitoring visit.
Ensures study recruitment goals and completion
timelines are met and makes suggestions to improve enrollment if
necessary.
Reviews source documents and Case
Report Forms (CRFs) for each subject in accordance with
country-specific regulations, ICH-GCP guidelines, and company SOPs
to assure timely, accurate, and quality data retrieval.
Maintains internal and external study files and
assures that regulatory and other documents are complete and
accurate in accordance with all requirements.
Supports administrative duties necessary for
in-house, study site and data management operations, under the
supervision of the clinical team.
Assists
Project Manager with study management.
Collects complete, monitored CRFs; forwards
these forms to Document Control; and documents that the forms were
collected.
Facilitates the timely resolution
of queries, either in-house or at the site, as required and tracks
any outstanding queries to ensure process is complete and timelines
are met.
Inventories and retrieves clinical
supplies and monitors disposition records.
Participates in the training and mentoring of
new CRAs, as requested.
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Salary: 70-90k, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Mid West & East Coast |
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| Job ID: |
PCR-05068-1 - Regional CRA |
| Description: |
Responsibilities include performing site visits
to monitor and ensure study/protocol compliance according to
GCPs/ICH, and other regulatory agency guidelines; Ensuring that the
rights, well-being and safety of human subjects are protected;
Assuring that the reported data is accurate, complete and verifiable
from source documents; and maintaining ongoing and continuous
professional communication with the clinical site and the study
team.
Requires Bachelor’s Degree in health
sciences or related field; Minimum 2 years CRA/Monitoring.
|
| |
Salary: to 85K, Job Type: Permanent, Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Texas |
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| Job ID: |
PCR-05068-11 - Regional CRA |
| Description: |
Responsibilities include:
Monitor assigned investigative sites
Conduct pre-study, initiation, interim
monitoring and close-out visits
Train
assigned investigative sites in GCP and ensure these sites are
conducting research according to protocol and Federal (GCP)
regulations
Review investigative sites’
regulatory documentation and ensure compliance with GCP
Monitor informed consent process
Serve as main point of contact with assigned
investigative sites
Review and update
clinical files at the assigned investigative sites
Initiate actions to ensure all assigned
investigative sites are in compliance with protocol and GCP Conduct
Source Document Verification of CRFs against medical records to
ensure CRFs are a valid representation of what happened to a subject
while participating in the study
Create and
properly file trip reports, follow-up letters and telephone contacts
for assigned investigative sites
Evaluate
and Resolve Data Queries
Evaluate study
query trends and interact with Study Team in improving data quality
• Assist investigative sites with timely and accurate resolution of
queries
Attend, participate and present at
Investigator Meetings
Effectively negotiate
and manage clinical study budgets for assigned sites
Act as a liaison between the company and
assigned investigative sites
Identify new
investigators for future company studies
Mentor new CRAs
Function as Lead CRA for assigned projects
Develop protocol-specific monitoring tools
Participate in study team meetings
Assist in the development of the study
Monitoring Plan and Study-specific monitoring report templates
Review draft CRF and provide feedback as
required
Co-monitor with CRAs from CROs for
assigned projects, as needed
Up to
approximately 80% domestic airline travel required, including
overnight stays
Comply with Celgene’s
corporate travel policy
Skills/Knowledge Required: •
Prior experience as a Clinical Research
Associate
Must have demonstrated
problem-solving abilities in overseeing clinical sites, and
demonstrated tactfulness and diplomacy in dealing with study
coordinators and physicians
Able to resolve
routine issues independently
Knowledge of
regulatory environment (FDA, ICH, GCP)
Excellent written and oral communication
skills
Working knowledge of SOPs relevant to
clinical research Ability to drive an automobile and have a valid
driver’s license
PREREQUISITES BA/BS or RN degree; 2+ years of
direct clinical study monitoring experience
|
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Salary: 95-100K, Job Type: Permanent, Total Exp: 2 - 3 Yrs, Start Date: ASAP,
Location: NYC |
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| Job ID: |
PCR-05068-12 - Regional CRA |
| Description: |
Responsibilities include:
Monitor assigned investigative sites
Conduct pre-study, initiation, interim
monitoring and close-out visits
Train
assigned investigative sites in GCP and ensure these sites are
conducting research according to protocol and Federal (GCP)
regulations
Review investigative sites’
regulatory documentation and ensure compliance with GCP
Monitor informed consent process
Serve as main point of contact with assigned
investigative sites
Review and update
clinical files at the assigned investigative sites
Initiate actions to ensure all assigned
investigative sites are in compliance with protocol and GCP Conduct
Source Document Verification of CRFs against medical records to
ensure CRFs are a valid representation of what happened to a subject
while participating in the study
Create and
properly file trip reports, follow-up letters and telephone contacts
for assigned investigative sites
Evaluate
and Resolve Data Queries
Evaluate study
query trends and interact with Study Team in improving data quality
• Assist investigative sites with timely and accurate resolution of
queries
Attend, participate and present at
Investigator Meetings
Effectively negotiate
and manage clinical study budgets for assigned sites
Act as a liaison between the company and
assigned investigative sites
Identify new
investigators for future company studies
Mentor new CRAs
Function as Lead CRA for assigned projects
Develop protocol-specific monitoring tools
Participate in study team meetings
Assist in the development of the study
Monitoring Plan and Study-specific monitoring report templates
Review draft CRF and provide feedback as
required
Co-monitor with CRAs from CROs for
assigned projects, as needed
Up to
approximately 80% domestic airline travel required, including
overnight stays
Comply with Celgene’s
corporate travel policy
Skills/Knowledge Required: •
Prior experience as a Clinical Research
Associate
Must have demonstrated
problem-solving abilities in overseeing clinical sites, and
demonstrated tactfulness and diplomacy in dealing with study
coordinators and physicians
Able to resolve
routine issues independently
Knowledge of
regulatory environment (FDA, ICH, GCP)
Excellent written and oral communication
skills
Working knowledge of SOPs relevant to
clinical research Ability to drive an automobile and have a valid
driver’s license
PREREQUISITES BA/BS or RN degree; 2+ years of
direct clinical study monitoring experience
|
| |
Salary: 95-100K, Job Type: Permanent, Total Exp: 2 - 3 Yrs, Start Date: ASAP,
Location: Boston Near
Logan Airport |
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| Job ID: |
PCR-05068-2 - Regional CRA |
| Description: |
Responsibilities include performing site visits
to monitor and ensure study/protocol compliance according to
GCPs/ICH, and other regulatory agency guidelines; Ensuring that the
rights, well-being and safety of human subjects are protected;
Assuring that the reported data is accurate, complete and verifiable
from source documents; and maintaining ongoing and continuous
professional communication with the clinical site and the study
team.
Requires Bachelor’s Degree in health
sciences or related field; Minimum 2 years CRA/Monitoring.
|
| |
Salary: to 85K, Job Type: Permanent, Total Exp: 2 Yrs,
Start Date: ASAP,
Location: California |
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| Job ID: |
PCR-05068-3 - Regional CRA |
| Description: |
Responsibilities include performing site visits
to monitor and ensure study/protocol compliance according to
GCPs/ICH, and other regulatory agency guidelines; Ensuring that the
rights, well-being and safety of human subjects are protected;
Assuring that the reported data is accurate, complete and verifiable
from source documents; and maintaining ongoing and continuous
professional communication with the clinical site and the study
team.
Requires Bachelor’s Degree in health
sciences or related field; Minimum 2 years CRA/Monitoring.
|
| |
Salary: to 85K, Job Type: Permanent, Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Flordia |
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| Job ID: |
PCR-05068-4 - Regional CRA |
| Description: |
Responsibilities include performing site visits
to monitor and ensure study/protocol compliance according to
GCPs/ICH, and other regulatory agency guidelines; Ensuring that the
rights, well-being and safety of human subjects are protected;
Assuring that the reported data is accurate, complete and verifiable
from source documents; and maintaining ongoing and continuous
professional communication with the clinical site and the study
team.
Requires Bachelor’s Degree in health
sciences or related field; Minimum 2 years CRA/Monitoring.
|
| |
Salary: to 85K, Job Type: Permanent, Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Northeast - NY/NJ/PA |
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| Job ID: |
TB-07277-1 - REGIONAL CRA I |
| Description: |
Under general supervision, the Regional
Clinical Research Associate I manages the implementation and conduct
of study protocols at research sites. Responsibilities include but
are not limited to: performing monitoring visits including site
qualification, initiation, periodic monitoring and close-out visits;
maintaining regular contact with study site to ensure protocol/GCP
compliance; participating in Investigator meetings and other study
training meetings as required; preparing for and participating in
Sponsor and FDA audits; preparing reports and communications
documentation.
Required qualifications: Associate’s degree or
equivalent combination of education and experience in a medical or
scientific discipline; significant technical, medical, or industry
experience in a clinical research setting; strong understanding of
Medical Terminology, Physiology, and Pathophysiology; basic
understanding of Good Clinical Practices; strong organizational
skills; the ability to multi-task; the ability to manage multiple
study sites and multiple studies; strong written and verbal
communication and diplomacy skills; professional demeanor and
appearance; ability to travel 75-85%.
Preferred qualifications: BS in scientific
discipline; 2+ years experience including at least 1 year of field
monitoring within a CRO or other clinical research setting. Oncology
experience required
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Salary: 60-90K, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Northeast & West Coast |
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| Job ID: |
CLM-03078-1 - Regional CRA Midwest |
| Description: |
My client is a highly respected leader in the
Pharmaceutical, Biotechnology and Medical Device Industries,
provides clinical research consulting and management services. We
are a rapidly growing CRO, offering competitive compensation and
excellent benefits, in a fast-paced team oriented environment.
Purpose of
Position:
We currently have multiple
regional Clinical Research Associate (CRA) positions available. As a
CRA, the primary focus of this position is on the implementation of
clinical studies for our clients, specifically study monitoring
responsibilities.
Requirements and Responsibilities:
Candidates will monitor clinical sites and
insure that all documentation is maintained and in compliance with
FDA/ICH guidelines.
Education & Experience:
We require RN/Bachelor's degree in the
biological sciences or related field, plus 2 years clinical research
experience. Must have strong interpersonal and communication skills
as well as excellent problem-solving ability.
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Salary: OPEN, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Midwest |
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| Job ID: |
PC-07186-7 - Regional CRA/Regional CRA II |
| Description: |
Regional CRA- BS/BS or RN plus 6+ months on
site monitoring experience
Regional CRA II- BS/BA or RN plus 18 months +
on-site monitoring for a pharma/biotech company or CRO with a total
of 3 years experience in clinical research, drug development, data
management
Both
positions require travel up to 80%
Please note that Regional CRA II's qualify for
the car allowance while Regional CRA's do not qualify
Must be within an hour
of a major 'International' airport |
| |
Salary: Open, Job Type: Permanent, Total Exp: 2+ Years,
Location: USA
Wide |
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| Job ID: |
DS-01118-1 - Senior CRA |
| Description: |
Company is a product based biopharmaceutical
business focused on developing novel treatments for respiratory and
CNS diseases. The principal product development strategy is to
create innovative therapies with large market potential to improve
safety, efficacy, and patient compliance. The Company’s main focus
is on the patient and in developing therapies that provide
convenient and differentiated patient benefits. Faster onset of
action, less invasive delivery (as compared to needle injection) and
treatment at the lowest effective dose as well as improved clinical
results are all benefits this company is targeting for the therapies
they have under development. They are building the company on this
basis by surrounding themselves with exceptionally focused,
diligent, and experienced colleagues. They strive in creating an
environment where teamwork, integrity, and accomplishment are
valued.
Function:
Monitors
clinical trials, study sites, and clinical data. Ensures compliance
with protocol and overall clinical objectives and GCP. Provides
administrative and project support to clinical programs with minimum
supervision. Interfaces with all project/clinical groups and
off-site personnel as needed in support of project and departmental
goals and responsibilities
Specific Responsibilities & Activities:
Manages with limited oversight clinical study sites including
managing study site start up, conduct and close-out. Assists with
the development and start up of clinical studies. Some input into
strategic operational development plans where requested. Ensure,
where relevant, that study sites follow SOPs and GCP. Prioritizes as
needed to ensure on-time completion of assigned study deliverables.
Assist with management of clinical trial material to ensure clinical
sites supplied when needed. Assists management of relationships with
vendors within and across studies. Assists in the recruitment,
mentoring and retention of key talent within Clinical Ops.
Understands the economic impact of decisions and maintains the
awareness of the business. Promotes the company as emerging
biopharmaceutical firm with interest and expertise in pulmonary
disease. Serves as a champion/proponent of
technology and
products while interfacing with site personnel and collaborators.
Aid in development of clinical study protocols and take ownership of
their implementation where appropriate.
Monitoring of clinical study sites (+/-CRO
staff) as required
Ensures identified
clinical study issues are resolved; implements and monitors
corrective action
Provide input into
development of Case Report Forms.
With
limited oversight, facilitate the development of study-specific
clinical trial materials.
Serve as primary
point of contact for site questions relating to study conduct
issues; liaise with appropriate study team members as needed.
Support site selection process.
Participate in departmental organizational
process improvement
Assist with contract
negotiation/review for vendors as needed
Management/support of selected vendors as
needed
Attend meeting(s) with external
vendors, CRO’s, Investigative sites, Investigator meetings and
scientific meetings as requested
Maintain
flexible approach to work as requested from time to time
Interacts effectively with other project and
development staff to ensure streamlined forward movement of clinical
projects
Education, Training &
Experience:
Bachelor's degree or equivalent. RN with
evidence of further study considered. Major course of study in
Science or Health-related preferred.
5
years experience in Clinical Research or related field
Proven track record to deliver key study
deliverables in support of operational milestones.
MUST be proficient in Microsoft Office/Windows,
and Microsoft Outlook. Specifically: MS Word, MS Excel, MS
Powerpoint and MS Project with excellent oral and written
communication skills.
Demonstrates good
understanding of ICH/GCP, and US FDA regulations as applied to
clinical research. Detail oriented with excellent organizational
skills.
Ability to prioritize and
multi-task while remaining calm and sensitive to
confidential/personal nature of material.
Ability to interpret instructions and
information under pressure and respond accordingly, with minimal
supervision as appropriate.
Must have
excellent communications and interpersonal skills with ability to
work in a global environment.
Must be
willing to travel to meet corporate and project goals as needed
(~30-50% of time).
|
| |
Salary: 95-105K, Job Type: Permanent, Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Mountian View, CA |
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| Job ID: |
IN-07177-1 - Senior CRA |
| Description: |
SUMMARY OF POSITION:
Responsible for the implementation and
management of clinical research projects with additional
responsibilities surrounding the management of investigational
sites.
ACCOUNTABILITIES:
Responsible for activities related to the
conduct of clinical trials and other projects in a timely, efficient
and GCP compliant manner.
ACTIVITIES:
Organize
and manage clinical research projects with minimal support of
supervisor, including but not limited to the following:
? Manage CROs and other CRAs at a project
level
? Coordinate supplies forecasting and
distribution
? Communicate across
departments and conduct project team meetings
Assure adherence to the protocol, standard
operating procedures (SOP's), ICH GCP and case report form (CRF)
guidelines, and Title 21 of the Code of Federal Regulations
(CFR).
Conduct Study Qualification,
Initiation, Interim Monitoring and Close-Out visits.
Perform ongoing training of Clinical Staff
including, but not limited to, Principle Investigators, Study
Coordinators, Sub-Investigators, and other site staff.
Facilitate and monitor adverse event
reporting.
Complete administrative tasks,
status reports, and computer assignments in a timely manner.
POSITION DEFINITION:
Reports to Manager, Clinical Research based
at the Clinton, NJ offices. Must possess the ability to travel
independently by air, car or train and be able to travel up to 65
percent.
REQUIREMENTS:
Preferred Minimum
Education
• Bachelors
degree in scientific discipline.
•
Bachelors degree, RN or equivalent.
Experience
• Four
years of clinical trial experience (at least 3 years monitoring
clinical trials) with a pharmaceutical, CRO or medical device
company.
• Minimum three years of clinical
trial field monitoring experience with a pharmaceutical, CRO or
medical device company.
Special Skills or Knowledge
• Certified Clinical Research Associate.
• Comprehensive understanding of the drug
development process.
• Strong communication
and organizational skills, with the ability to prioritize multiple
projects and work both independently and within a team.
• Must possess the ability to communicate with
medical professionals.
• Working knowledge
of FDA ICH/GCPs .
• Comprehensive
understanding of the drug development process.
• Strong communication and organizational
skills, with the ability to prioritize multiple projects and work
both independently and within a team.
• Must
possess the ability to communicate with medical professionals.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 3 Yrs,
Start Date: ASAP,
Location: Clinton, NJ |
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| Job ID: |
PN-11307-2 - Sr CRA West Coast Regional |
| Description: |
Our client, a growing CRO is looking for
individuals with experience monitoring oncology studies. Several
positions exist, depending upon your experience and situation.
This is a CRO that cares for and rewards their
clinical monitoring talent. Some of the extras they provide their
CRAs include:
• One airline club memberships
to all CRAs who travel
• Focus on limited
number of Protocols (typically 2-3)
•
Light-weight laptops
• Excellent time
management system and superior connectivity
• Excellent career path opportunities (PM)
whether office or home-office based
•
Experienced management team. Regional CRAs have dedicated line
managers
• Team environment, including
annual meetings
• Company pays for 1
professional membership/year i.e. SOCRA, ACRP
• Reimbursement for professional exams and
certifications
• Quick turnaround on expense
reimbursement
• Car Allowance for certain
levels
Position can be office based (San
Diego, CA) or home-based (must reside within the Pacific Time Zone:
e.g. CA, AZ, NV, or Canada.)
Senior CRA:
Responsibilities: Assist in managing
large-scale clinical trial projects or function as project manager
for small-scale projects, ensuring on-time, on-budget performance,
on site monitoring of clinical trials (average of 30% travel),
Protocol/CRF development; investigator recruitment; in-house review
of clinical data; generation of project management reports; and
assisting in the preparation of clinical study reports. Travel will
average 50% - 60%.
Regional CRA
Responsibilities: Monitor Investigator sites
for GCP/ICH compliance, Investigator recruitment, site selection,
collect and review clinical data. Regional CRAs travel up to 80% -
Travel is primarily regional with day/overnight trips. No
coast-to-coast travel!
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Salary: Open, Job Type: Permanent, Total Exp: 2+ Years,
Location: Westcoast
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| Job ID: |
PC-07186-2 - Sr. CRA |
| Description: |
All offices to be considered
3.5 years clinical
research experience required plus 24 months of monitoring
experience. Project Lead and Oncology experience required.
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 3.5+ years, Location: Blue Bell, PA, Princeton, NJ, Chicago, IL,San
Diego, CA |
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| Job ID: |
PCR-10276-1 - Sr. CRA |
| Description: |
Responsibilities:
As a
member of a therapeutically aligned Clinical Study Management Team,
the candidate will: monitor (pre-study, initiation, routine, and
close-out visits) at investigator sites for GCP/ ICH compliance
according to SOPs; recruit Investigators and negotiate budget for
participation in clinical trials; assist in protocol and case report
form development; review clinical data; generate project management
reports; prepare clinical study reports (CSRs); prepare and process
serious adverse event ( SAE ) reports; review and verify CRFs and
other clinical data for completeness and accuracy; review tables and
listings generated from study data.
Requirements:
Bachelor
degree required preferably in the life sciences; advanced degree a
plus
Three to five years clinical research
experience with a minimum of 2-4 year's direct monitoring
experience. |
| |
Salary: 70-80K + 10% bonus, Job Type: Permanent, Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Piscataway, NJ and Bridgewater, NJ |
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| Job ID: |
RG-11267-3 - Sr. CRA/Clinical Trial Manager |
| Description: |
Job Description:
Summary: Coordinates and implements clinical
research projects and is involved with writing protocols and
identifying, qualifying, and training clinical sites to conduct
clinical trials. Oversees the collection of data to ensure
compliance with
protocol and the clinical
research project bjectives as well as FDA / ICH / GCP regulations
and guidelines. Must be able to travel to field sites to assist with
clinical studies. Essential Duties and Responsibilities include, but
are not limited to
the following:
-Interacts regularly with CRO, central
laboratory, and IVRS systems.
-Follows
established clinical study standards and procedures to plan and
conduct clinical research studies.
-Assists
with/and/or may play a lead role in the development of procedures
and tools for data collection.
-Work is
assigned through general instructions given for routine work; more
detailed instruction is provided for new projects.
-Applies knowledge of company policies and
standard practices to resolve problems.
-Analyzes issues and uses judgment to make
decisions.
-Escalates non-standard problems
or issues as may be required.
-Compiles and
maintains regular status reports of study progress.
-Assists with and/or may play a lead role in
the development of study documents including protocols, informed
consent forms, and procedure manuals.
-Maintains open communication channels with
study sites and members of the study team.
Knowledge and
Specialized Skills:
-Analytical problem
solving experience.
-Working knowledge of
the clinical research process and regulations/guidelines.
-Can effectively communicate in large or small
group settings.
-Understands current and
possible future business trends and information.
-Clinical Research knowledge is essential.
-Can effectively write so needed messages are
clear and understood.
Education and Experience: A Bachelor's degree
(BS) from an accredited college or university plus four (4) or more
years of industry related experience is required. A Master's degree
(MS) and two (2)or more years of experience is also accepted. Some
Sr. CRA/Clinical Study Manager positions
may require additional training within the healthcare field.
Therapeutic areas:
oncology, opthamology, and inflammatory diseases.
Travel: to 25% Relocation Plan
available. |
| |
Salary: to 100k, Job Type: Permanent, Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
PCR-04148-1 - Sr. In-House CRA |
| Description: |
Description: The primary purpose of this
position is to assist study management in the execution of clinical
studies according to protocol and GCP standards. The high-level,
routine deliverables consist of: research site identification a d
training, study-specific CRA training and management, weekly
enrollment tracking by site, case report form and data clarification
form management with sites (including collection and quality),
potential drug abuse or diversion reporting and follow-through
between research sites and the company, and general communication
with sites to serve as a information portal and resource.
Skills: Has
demonstrated knowledge of, and competence in, application of
CFRs, GCPs and ICH guide1ines. .Has
demonstrated the use of good communication skills, command of
medical terminology and of the application of scientific/medical and
clinical concepts used to conduct clinical trials, and preferably, a
competent working knowledge and understanding of scientific and
medical processes in previously assigned therapeutic areas. .Has
demonstrated the knowledge and ability to effectively manage sites
and GRAS within a clinical trial with a minimum of supervision. MS
Word, MS Excel, MS Project
Experience: Minimum of 2-years industry
experience (including at least 1 year as a CRA) with a minimum of 1
year experience as a Sr. CRA
|
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Salary: $60-65 per hour, Job Type: Contract,
Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Stamford,
CT |
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