Position Summary
We are seeking an experienced Clinical Research Coordinator (CRC) to support the successful execution of interventional clinical trials within an academic medical center, hospital, clinic, or healthcare research environment. The Clinical Research Coordinator will partner closely with Principal Investigators, research staff, sponsors, and clinical teams to ensure studies are conducted in compliance with study protocols, Good Clinical Practice (GCP), institutional policies, and regulatory requirements.
This role will support clinical trials throughout the study lifecycle, including startup, recruitment, enrollment, participant visits, data management, and study closeout. Workload may vary depending on study activity, enrollment needs, participant visits, and project timelines. The coordinator may support multiple studies simultaneously and is responsible for accurately tracking time by study assignment.
Key Responsibilities
- Coordinate day-to-day clinical trial activities from study startup through closeout.
- Review study protocols, schedules of events, informed consent forms, and study manuals to ensure compliance with protocol requirements.
- Collaborate with Principal Investigators, sponsors, and research teams to execute study-related activities.
- Identify, recruit, pre-screen, and screen potential study participants using approved recruitment methods.
- Schedule and coordinate participant visits, follow-up appointments, assessments, and study procedures.
- Obtain and document informed consent when authorized by protocol, institutional requirements, and credentials.
- Administer or coordinate investigational products, study medications, and protocol-specific procedures as permitted.
- Perform or coordinate phlebotomy, specimen collection, processing, storage, and shipment activities.
- Prepare participant charts, source documentation, and study materials for clinic visits.
- Maintain accurate and complete source documentation and study records.
- Enter and manage study data in electronic data capture (EDC) systems and research databases.
- Resolve data queries and assist with data reconciliation activities.
- Track participant progress, study visits, adverse events, protocol deviations, and outstanding action items.
- Maintain essential regulatory documents and study files.
- Collaborate with pharmacy, laboratory, nursing, finance, regulatory, and operational teams.
- Participate in sponsor meetings, site initiation visits, monitoring visits, and audits.
- Complete all required sponsor, protocol-specific, and institutional training.
- Ensure compliance with HIPAA, GCP, FDA regulations, and institutional requirements.
- Accurately document and allocate time worked across assigned studies.
Required Qualifications
- Bachelor's degree in Nursing, Life Sciences, Healthcare, or a related field, or equivalent clinical research experience.
- Prior experience coordinating clinical research studies in a hospital, academic medical center, clinic, or research setting.
- Experience supporting interventional clinical trials.
- Strong knowledge of GCP, informed consent processes, source documentation, and research regulations.
- Experience collaborating with Principal Investigators, clinical staff, sponsors, and research teams.
- Ability to independently manage multiple priorities and study timelines.
- Strong organizational, communication, and documentation skills.
- Experience with electronic health records (EHR), electronic data capture systems, and Microsoft Office applications.
- Ability to work onsite as required for study visits and participant-facing activities.
Preferred Qualifications
- Active Registered Nurse (RN) license.
- Phlebotomy experience.
- Experience administering investigational products or study medications.
- Experience with PK sampling, timed blood draws, specimen processing, and protocol-driven clinical procedures.
- Experience supporting endocrinology, oncology, internal medicine, or other complex therapeutic-area studies.
- Experience using Epic, REDCap, Medidata Rave, or other EDC platforms.
- ACRP or SOCRA certification.
Schedule
- Part-time or variable-hour assignment based on study requirements.
- Hours may fluctuate based on enrollment, participant visits, startup activities, and study milestones.
- Flexible scheduling with a combination of onsite clinical support and remote administrative work when appropriate.
- Ability to support multiple studies and accurately track hours by project.
Pay: $40.00 - $48.00 per hour
Work Location: In person
