JOB SUMMARY
We are seeking a skilled and compassionate Clinical Research Nurse to join our clinical research unit. As a primary point of contact for study participants, the Principal Investigator (PI), Clinical Study Manager (CSM), and Department Managers, this role ensures the safe and compliant conduct of clinical studies. The ideal candidate will be a Registered Nurse with hospital experience, strong emergency response skills, and proficiency in IV and phlebotomy procedures. This position requires professionalism, leadership, and a commitment to patient care and regulatory compliance.
CORE ESSENTIAL SKILL SETS
- Must be a Registered Nurse with active in-state licensure.
- Hospital experience required.
- Ability to handle emergencies effectively.
- Prior healthcare experience.
- Proficiency in drawing blood and IV administration.
SCREENINGS
- Basic background check.
- 11-panel drug test including fentanyl.
KEY RESPONSIBILITIES
- Perform study conduct procedures in strict compliance with study protocols, Good Clinical Practice (GCP), SOPs, QA/QC procedures, OSHA guidelines, and applicable regulations.
- Monitor participant well-being and safety through active assessment and serve as a visible point of contact.
- Facilitate verbal directions from the PI to study participants and staff, ensuring proper follow-through.
- Assist PI with review of laboratory data for participant selection, randomization, and safety monitoring.
- Provide ongoing assessment of participants to identify Adverse Events (AEs), document and report events, and follow up as needed.
- Communicate study progress to PI, CSM, and clinical study team members.
- Notify PI, CSM, and management immediately upon occurrence of Serious Adverse Events (SAEs) and initiate documentation.
- Enforce study rules and handle participant complaints to maintain satisfaction.
- Maintain compliant, clear, and accurate study charts and documentation of AEs and concomitant medications.
- Act as floor leader in the absence of the CSM, mentoring and assisting clinical staff.
- Administer study and concomitant medications per protocol, with accurate documentation.
- Coordinate with scheduling to ensure coverage of clinical conduct activities.
- Provide protocol training and performance feedback to clinical study team members.
- Oversee completion of End of Study or Early Termination activities, including follow-up of outstanding items.
- Provide administrative and operational support to ensure successful study conduct.
QUALIFICATIONS
- Nursing degree and active in-state RN licensure required.
- Advanced Life Support (ALS) certification required.
- 1–2 years of experience in a clinical research environment preferred.
- Equivalent combinations of education and experience may be considered.
KNOWLEDGE, SKILLS, & ABILITIES
- Strong leadership skills with ability to mentor and guide team members.
- Excellent customer service and public relations skills.
- Professional communication skills, both verbal and written, with diverse populations.
- Ability to work independently and manage multiple priorities under tight deadlines.
- Strong organizational and time-management skills with attention to detail.
- Ability to multi-task and function effectively within a team environment.
- Commitment to patient safety, regulatory compliance, and ethical standards.
WORKING CONDITIONS
- Clinical research unit environment with direct patient interaction.
- Requires flexibility to manage emergencies and adapt to evolving study needs.
- Collaboration across multidisciplinary teams including investigators, managers, and technicians.