Summary: The Clinical Research Nurse is responsible for supporting the clinical aspects of the research program through patient screening, study-related clinical visits, safety monitoring, and collaboration with investigators and research staff. This role focuses on the direct clinical care and evaluation of research participants without outpatient and procedural settings.
The Clinical Research Nurse works closely with clinical investigators, coordinators, and regulatory staff to ensure that research participants receive safe, protocol-compliant care, while supporting efficient study execution.
The position serves as a bridge between clinical care and research operations within the department’s portfolio of device and interventional clinical trials.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Clinical Research Visits
· Conduct protocol-required outpatient visits including:
o Pre-operative evaluations
o Post-operative follow-up
o Protocol-specific clinical assessments
o Vital signs, clinical history, and documentation
· Ensure that clinical data collected during visits aligns with protocol requirements and 21 CFR / GCP regulations
Participant Screening & Enrollment Support
· Review patient charts and clinical data to identify potential study candidates
· Assist investigators and coordinators in:
o Evaluating eligibility criteria
o Discussing study participation with potential patients
o Obtaining informed consent, when appropriate
· Support efficient patient screening within clinic workflows
Safety Monitoring
· Monitor participants for:
o Adverse events
o Serious adverse events
o Clinical changes during study participation
· Document safety findings and collaborate with investigators to ensure appropriate reporting and follow-up
Clinicl Query Resolution
· Assist research staff and investigators in addressing clinical queries from sponsors and monitors
· Provide clinical insight regarding:
o Participant status
o Protocol-related clinical questions
o Safety events and documentation
Coordination with Clinical Teams
· Work closely with physicians, surgical staff, and clinical personnel to integrate research activities into routine clinical workflows
· Support efficient scheduling and coordination of research visits within the outpatient surgical center
Documentation & Compliance
· Maintain accurate clinical documentation consistent with protocol requirements and regulatory standards
· Ensure clinical records support sponsor monitoring, audits, and regulatory review
Collaboration with Research Staff
· Partner with CRCs and regulatory staff to ensure seamless execution of study procedures
· Assist in maintaining high standards of participant care and protocol compliance
Growth within the Research Nurse role includes:
· Increasing clinical judgment
· Increasing confidence in managing protocol-related clinical situations
· Ability to anticipate participant needs and study requirements
Potential future pathways include:
· Senior Clinical Research Nurse
· Clinical Research Program Leader
· Clinical Research Coordinator
· Specialized Research Nursing
Qualifications
Required
· Registered Nurse (RN) licensure
· Clinical experience in surgical, procedural, or outpatient settings
· Strong clinical assessment skills
· Ability to collaborate across multidisciplinary teams
Preferred
· Experience in clinical research
· Familiarity with GCP
· Experience with device trials
Neurosurgical or cardiovascular clinical exposure
Pay: $70,000.00 - $78,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience:
- Clinical research: 1 year (Preferred)
- Outpatient: 1 year (Required)
License/Certification:
Work Location: In person
