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Advanced Recruiting Partners · Durham, North Carolina
Position Summary
The
Lead Clinical Research Associate (Lead CRA)
is responsible for leading site monitoring activities across assigned clinical trials while ensuring compliance with
International Council for Harmonisation Good Clinical Practice (ICH-GCP)
guidelines, company SOPs, and regulatory requirements. The Lead CRA serves as the primary liaison between the sponsor and investigative sites, providing oversight, mentoring CRAs, and supporting clinical trial execution.
Key
Clinical Trial Monitoring
Lead and conduct
site qualification, initiation, monitoring, and close-out visits
for clinical trials.
Ensure compliance with
protocols, regulatory requirements, and GCP guidelines .
Review
source documentation and Case Report Forms (CRFs)
for accuracy and completeness.
Track patient enrollment, protocol adherence, and data quality.
Leadership & Oversight
Act as the
lead CRA on assigned studies , coordinating monitoring activities across multiple sites.
Provide
mentorship and training
to junior CRAs.
Assist clinical project managers with
study planning, timelines, and monitoring strategies .
Participate in
investigator meetings and sponsor oversight meetings .
Site & Investigator Management
Serve as the
primary contact for study investigators and site staff .
Ensure sites are properly trained on protocols and study procedures.
Identify and resolve
site performance issues and protocol deviations .
Regulatory & Documentation
Ensure compliance with regulatory authorities such as the
U.S. Food and Drug Administration (FDA) .
Maintain accurate
Trial Master File (TMF)
documentation.
Prepare monitoring reports and follow-up letters.
Risk Management & Quality
Identify risks related to patient safety, data integrity, or protocol compliance.
Support
audit and inspection readiness .
Collaborate with clinical operations, data management, and medical teams.
Required
Bachelor’s degree in life sciences, nursing, pharmacy, or related field.
Experience working in
biotechnology, pharmaceutical, or CRO environments .
Details
| Company | Advanced Recruiting Partners |
| Location | Durham, North Carolina |
| Type | FULL TIME |
| Niche | Full-time |