Clinical Research Coordinator III
About The Position
The Institute for Medical Research (IMR), an affiliate of the Durham VA Health Care System (DVAHCS), is seeking a Clinical Research Coordinator III (CRC3) to support clinical research studies led by Dr. Christopher Woods and his team. This role will focus on industry clinical trials and observational research within various sections of the Durham VA Medical Center, including infectious diseases, pulmonology, hepatology, cardiology, and dermatology. Key responsibilities include study start-up and close-out, participant recruitment, enrollment, and follow-up, biospecimen collection and processing, research data collection and entry, and ensuring regulatory compliance with review boards. The CRC3 will also mentor and supervise junior staff and will be a patient-facing role. The first-level manager is the Research Program Manager, and the second-level manager is Dr. Christopher Woods. The position involves collaboration with research personnel, MDs, PhDs, and other clinical staff.
Requirements
- Bachelor's degree in biology, public health, clinical research, or other related scientific field.
- 5 or more years full-time patient-facing clinical research experience.
- Must reside within the State of North Carolina and maintain a reasonable commuting distance to their assigned work location.
Nice To Haves
- A relevant clinical or clinical research certification may substitute for 1 year experience.
Responsibilities
- Coordinate and oversee assigned clinical research studies in accordance with approved protocols.
- Provide input related to study budgets, timelines, staffing, scheduling, and operational needs.
- Develop, implement, and manage study procedures.
- Identify, screen, recruit, and consent eligible research participants.
- Conduct participant follow-up visits and maintain ongoing engagement.
- Apply sound judgment and problem-solving skills to address protocol deviations, recruitment challenges, and operational barriers.
- Coordinate with study sponsors, contractors, Principal Investigators, and research team members for sponsored or multi-site studies.
- Prepare and submit protocols, informed consent forms, HIPAA authorizations, and other regulatory documents for IRB review.
- Prepare and submit amendments, continuing reviews, audits, adverse event reports, and other IRB-required documentation.
- Maintain regulatory binders and documentation in collaboration with administrative staff.
- Maintain accurate digital and/or paper study records, including informed consent forms, HIPAA documentation, case report forms, EMR research documentation, and participant payment records.
- Review study records and binders for completeness, accuracy, and compliance with applicable regulations.
- Resolve missing or inaccurate documentation and follow up with study participants as needed.
- Assist with and train staff on procurement, processing, storage, and shipment of biospecimens.
- Coordinate biospecimen handling, including blood, swabs, and, when applicable, urine and stool samples.
- Facilitate shipment and receipt of specimens to and from external laboratories or facilities.
- Ensure biospecimen processing procedures are followed accurately and consistently.
- Manage day-to-day operational decisions related to assigned study protocols.
- Assist with training and mentorship of junior research staff.
- Collaborate with other research staff to ensure study milestones and objectives are met.
- Update and maintain standard operating procedures (SOPs).
- Participate in study meetings, conference calls, and leadership discussions.
- Maintain and develop positive sponsor relationships as related to assigned studies.
- Support current and future collaborations with clinical departments and VHA research partners.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
