We are seeking an experienced Clinical Research Nurse / Clinical Research Coordinator to join our growing team. This is a dual-role position that combines nursing responsibilities with hands-on study coordination. The ideal candidate is already experienced in sponsor-funded clinical research and can quickly integrate into an active research environment.
Responsibilities
- Coordinate Phase II-IV sponsor-funded clinical trials from screening through study completion.
- Conduct study visits in accordance with protocol requirements.
- Review medical history, concomitant medications, and adverse events with participants.
- Perform protocol-required clinical procedures within scope of licensure and delegation.
- Support investigational product preparation and accountability activities as permitted b y protocol
and site delegation.
- Assist with participant education and answer protocol-related medical questions within scope of practice.
- Complete source documentation, eSource, EDC, and query resolution accurately and promptly.
- Maintain study regulatory documentation and assist with essential document management.
- Communicate effectively with sponsors, CROs, monitors, laboratories, and study participants.
- Participate in monitoring visits, audits, and sponsor interactions.
- Serve as lead coordinator on assigned studies and help ensure enrollment, protocol compliance, and data quality goals are achieved.
- Collaborate closely with investigators, nurse practitioners, coordinators, regulatory staff, and leadership.
Requirements:Qualifications
Required
- Current Tennessee RN or LPN license in good standing.
- Minimum of 2 years of sponsor-funded clinical research experience.
- Previous experience serving as a Clinical Research Coordinator.
- Strong understanding of ICH-GCP and FDA regulations.
- Experience with EDC systems and electronic source documentation.
- Excellent organizational skills and attention to detail.
- Ability to independently prioritize multiple studies and competing deadlines.
- Professional communication skills with patients, sponsors, CROs, and monitors.
Preferred
- Experience coordinating pulmonary, respiratory, internal medicine, and metabolic studies.
- Experience performing clinical assessments, specimen processing, ECGs, spirometry, or other
protocol-required procedures.
- ACRP or SOCRA certification (or willingness to obtain certification).
The right candidate is:
- Able to become productive quickly with minimal onboarding.
- Comfortable working independently while collaborating closely with the research team.
- Highly organized and able to manage multiple active studies simultaneously.
- Adaptable in a fast-paced environment where priorities can shift throughout the day.
- Committed to providing outstanding participant care while maintaining protocol compliance and data integrity.
- Proactive, dependable, and willing to take ownership of assigned studies.
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