JOB SUMMARY
The Clinical Research Nurse serves as a primary point of contact for study participants, the Principal Investigator (PI), Clinical Study Manager (CSM), and Department Managers in all study conduct and participant-related matters on the clinical research unit floor. This role requires strong clinical skills, adherence to regulatory standards, and the ability to ensure participant safety while supporting study execution.
ESSENTIAL FUNCTIONS
- Perform study conduct procedures in strict compliance with protocols, Good Clinical Practice (GCP), SOPs, QA/QC procedures, OSHA guidelines, and applicable regulations
- Monitor participant well-being and safety through active assessment and visibility
- Facilitate PI directions to participants and staff, ensuring appropriate follow-through
- Assist PI with review of laboratory data for participant selection, randomization, and safety monitoring
- Assess study subjects for Adverse Events (AEs), document and report findings, and provide follow-up care as needed
- Communicate study progress to PI, CSM, and clinical study team
- Notify PI, CSM, and management team of Serious Adverse Events (SAEs) and initiate documentation
- Enforce rules and handle participant complaints effectively
- Maintain compliant and accurate study charts, AE documentation, and concomitant medication records
- Act as floor leader in absence of CSM, mentoring staff and supporting study conduct
- Administer study and concomitant medications per protocol with accurate documentation
- Coordinate with scheduling department to ensure coverage of clinical activities
- Provide protocol training and performance feedback to staff
- Oversee completion of End of Study or Early Termination activities, including follow-up for outstanding items
- Provide administrative and operational support for successful study conduct
CORE ESSENTIAL SKILL SETS
- Must be a Registered Nurse (RN)
- Hospital experience required
- Ability to handle emergencies
- Healthcare experience required
- Proficiency in blood draws and IV skills
QUALIFICATIONS
Education:
Nursing degree and in-state RN licensure required
Experience:
- 1–2 years of experience in a clinical research environment preferred
- Equivalent combination of education and experience may be considered
Certification/Licensure:
Advanced Life Support (ALS) required
KNOWLEDGE, SKILLS & ABILITIES
Strong leadership skills
- Excellent customer service and public relations experience
- Professional verbal and written communication skills with diverse participants
- Ability to work independently and manage multiple priorities under tight deadlines
- Strong organizational and time-management skills with attention to detail
- Ability to collaborate effectively within a team environment