Senior Clinical Research Nurse

Primary role: Licensed registered nurse providing care/assessments for healthy volunteers and patients in a Phase I clinical research unit. Disseminates study information to CRNs for documentation, performance improvement, and PIMS upgrades. Provides study support within defined scope.

Responsibilities:
- Facilitate Phase I study activities; maintain safety/confidentiality; evaluate adverse events and manage timely safety reporting; review protocols and informed consent forms; identify and communicate potential issues.
- Perform protocol-required nursing activities per SOPs and regulatory guidelines (CFR, ICH, GCP); coordinate nursing activities with Principal Investigator, study physicians, Recruiting/Screening, Data Systems, and others.
- Support quality/compliance initiatives; maintain accurate source data in PIMS/other documents; help resolve source discrepancies.
- Assist with protocol-specific training and informed consent; train new nursing personnel; update/implement schedule changes.
- Resolve study questions/issues; maintain study forms/tools for accurate tracking.
- Provide guidance for protocol activities; manage multiple concurrent tasks.
- Train team members through trial activities and revised processes; provide in-servicing to nursing units and lab staff.
- Report adverse drug reactions with required documentation.
- Provide direct patient care (drug administration, lab draws, appointment coordination, follow-up, side-effect management) with discretion and confidentiality.

Qualifications:
- Associate Degree in Nursing; Baccalaureate preferred.
- 5+ years nursing experience and/or >4 years clinical research experience.

Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) eligibility.
- Eligible for short-term incentive programs.