Barrington James
Clinical Research Coordinator (CRC) - Job Description
Employment Type:
Full‑Time/Contract: Six months contract to permanent hire
Job Summary The Clinical Research Coordinator (CRC) plays a critical role in the planning, coordination, and conduct of clinical trials under the direct supervision of the Principal Investigator (PI). The CRC ensures that all clinical research activities are executed in accordance with the study protocol, Standard Operating Procedures (SOPs), institutional policies, and all applicable regulatory guidelines, including
Good Clinical Practice (GCP)
and
ICH guidelines . The ideal candidate is highly organized, detail‑oriented, and committed to maintaining the integrity and quality of clinical trial data.
Key Responsibilities
Regulatory Compliance and Study Documentation
Maintain comprehensive regulatory files
(Investigator Site File – ISF) for all assigned studies, ensuring all essential documents are current and inspection‑ready.
Manage communication and submissions with the Institutional Review Board (IRB) , including initial submissions, continuing reviews, amendments, and study closures, to ensure ethical and regulatory oversight.
Prepare and conduct visits (Qualifying Visits –
QV , Site Initiation Visits –
SIV , Interim Monitoring Visits –
IMVs , Close‑Out Visits –
COV ) with sponsor/CRO teams.
Patient Recruitment and Study Execution
Recruit and screen potential patients
for eligibility according to the study inclusion/exclusion criteria.
Execute the Informed Consent process
with eligible participants, ensuring all aspects are performed in strict adherence to
ICH and GCP guidelines .
Schedule and conduct study visits , performing all
assessments and procedures
(including
vitals, ECG , and other required study assessments) exactly as outlined in the study protocol.
Document all study visits meticulously in source documents
following the
ALCOA‑CCC
principles (Attributable, Legible, Contemporaneous, Original, Accurate; Complete, Consistent, Enduring).
Investigational Product and Specimen Management
Monitor, dispense, and collect investigational product (IP)
in accordance with protocol and sponsor requirements.
Maintain strict IP accountability logs and temperature logs , reporting any
temperature excursions
immediately and working in
Interactive Response Technology (IRT)
systems for randomization and drug supply management.
Perform phlebotomy
(blood draw) and collect
urine samples ;
process, package, and ship
all blood and urine specimens according to protocol specifications and IATA guidelines.
Data Management and Safety Reporting
Enter source document data
into the respective
Electronic Data Capture (EDC) vendor system
(e.g., Medidata RAVE) in a timely manner.
Respond to data queries
from the sponsor/CRO promptly and accurately.
Record all adverse events (AEs) and serious adverse events (SAEs)
per sponsor and regulatory guidance.
Maintain timely follow‑up
with the participant to document the resolution of the adverse event.
Qualifications Required:
Bachelor’s degree in a health‑related field (e.g., nursing, biology, public health) or equivalent relevant experience.
Minimum of 1–3 years of experience working as a Clinical Research Coordinator or in a related research capacity.
Strong working knowledge of
GCP/ICH guidelines
and FDA regulations.
Proficiency in performing
phlebotomy
and basic laboratory specimen processing.
Preferred:
Certification as a Certified Clinical Research Coordinator (CCRC) or equivalent.
Experience with multiple
EDC systems
(e.g., Medidata RAVE).
Familiarity with complex protocols and multiple therapeutic areas.
Seniority Level Associate
Employment Type Full‑Time/Contract: Six months contract to permanent hire
Job Function Research
Industries Research Services
#J-18808-Ljbffr
Full‑Time/Contract: Six months contract to permanent hire
Job Summary The Clinical Research Coordinator (CRC) plays a critical role in the planning, coordination, and conduct of clinical trials under the direct supervision of the Principal Investigator (PI). The CRC ensures that all clinical research activities are executed in accordance with the study protocol, Standard Operating Procedures (SOPs), institutional policies, and all applicable regulatory guidelines, including
Good Clinical Practice (GCP)
and
ICH guidelines . The ideal candidate is highly organized, detail‑oriented, and committed to maintaining the integrity and quality of clinical trial data.
Key Responsibilities
Regulatory Compliance and Study Documentation
Maintain comprehensive regulatory files
(Investigator Site File – ISF) for all assigned studies, ensuring all essential documents are current and inspection‑ready.
Manage communication and submissions with the Institutional Review Board (IRB) , including initial submissions, continuing reviews, amendments, and study closures, to ensure ethical and regulatory oversight.
Prepare and conduct visits (Qualifying Visits –
QV , Site Initiation Visits –
SIV , Interim Monitoring Visits –
IMVs , Close‑Out Visits –
COV ) with sponsor/CRO teams.
Patient Recruitment and Study Execution
Recruit and screen potential patients
for eligibility according to the study inclusion/exclusion criteria.
Execute the Informed Consent process
with eligible participants, ensuring all aspects are performed in strict adherence to
ICH and GCP guidelines .
Schedule and conduct study visits , performing all
assessments and procedures
(including
vitals, ECG , and other required study assessments) exactly as outlined in the study protocol.
Document all study visits meticulously in source documents
following the
ALCOA‑CCC
principles (Attributable, Legible, Contemporaneous, Original, Accurate; Complete, Consistent, Enduring).
Investigational Product and Specimen Management
Monitor, dispense, and collect investigational product (IP)
in accordance with protocol and sponsor requirements.
Maintain strict IP accountability logs and temperature logs , reporting any
temperature excursions
immediately and working in
Interactive Response Technology (IRT)
systems for randomization and drug supply management.
Perform phlebotomy
(blood draw) and collect
urine samples ;
process, package, and ship
all blood and urine specimens according to protocol specifications and IATA guidelines.
Data Management and Safety Reporting
Enter source document data
into the respective
Electronic Data Capture (EDC) vendor system
(e.g., Medidata RAVE) in a timely manner.
Respond to data queries
from the sponsor/CRO promptly and accurately.
Record all adverse events (AEs) and serious adverse events (SAEs)
per sponsor and regulatory guidance.
Maintain timely follow‑up
with the participant to document the resolution of the adverse event.
Qualifications Required:
Bachelor’s degree in a health‑related field (e.g., nursing, biology, public health) or equivalent relevant experience.
Minimum of 1–3 years of experience working as a Clinical Research Coordinator or in a related research capacity.
Strong working knowledge of
GCP/ICH guidelines
and FDA regulations.
Proficiency in performing
phlebotomy
and basic laboratory specimen processing.
Preferred:
Certification as a Certified Clinical Research Coordinator (CCRC) or equivalent.
Experience with multiple
EDC systems
(e.g., Medidata RAVE).
Familiarity with complex protocols and multiple therapeutic areas.
Seniority Level Associate
Employment Type Full‑Time/Contract: Six months contract to permanent hire
Job Function Research
Industries Research Services
#J-18808-Ljbffr