The Clinical Research Nurse coordinates and conducts the practice’s nephrology clinical research program, supporting study participants from initial screening and informed consent through study close-out. The role delivers safe, protocol-driven patient care while ensuring that each study is conducted in compliance with Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and Institutional Review Board (IRB) requirements.
Working closely with the Principal Investigator, sub-investigators, sponsors, and clinical research organizations, the Clinical Research Nurse serves as the primary day-to-day contact for study participants and as a steward of participant safety, data quality, and regulatory integrity across the practice’s nephrology trials.
Essential Job Responsibilities
Participant Recruitment & Informed Consent
· Screen, recruit, and enroll eligible participants in accordance with approved study protocols.
· Obtain and document informed consent under IRB-approved procedures prior to any study activities.
· Serve as the primary point of contact for study participants and coordinate visit scheduling and follow-up.
· Track screening, enrollment, and retention against established study targets.
Study Conduct & Clinical Care
· Conduct protocol-required study visits, including vital signs, ECGs, and clinical assessments.
· Collect, process, and ship laboratory specimens (blood and urine) per protocol and laboratory manuals.
· Administer and dispense investigational product and maintain accurate product accountability.
· Provide safe, protocol-driven nursing care and monitor participants throughout their study participation.
Safety Monitoring & Reporting
· Identify, document, and report adverse events and serious adverse events within required timelines.
· Monitor participant safety and escalate concerns promptly to the Principal Investigator.
· Ensure ongoing adherence to the protocol and to applicable safety-reporting requirements.
Regulatory Compliance & Data Management
· Maintain regulatory binders, source documentation, and case report forms.
· Enter study data accurately and resolve queries within electronic data capture (EDC) systems.
· Ensure compliance with GCP, ICH, FDA (21 CFR), HIPAA, and IRB requirements.
· Support IRB submissions, continuing reviews, protocol amendments, and study start-up and close-out.
· Prepare for and support sponsor monitoring visits and internal and external audits.
Coordination & Site Operations
· Coordinate with investigators, sponsors, CROs, laboratories, and imaging vendors.
· Manage study supplies, equipment, and documentation for assigned trials.
· Contribute to study feasibility assessments and site initiation activities.
Qualifications
Education & Experience
· Active, unrestricted Registered Nurse (RN) license in the state of practice required; BSN preferred.
· Minimum of two (2) years of clinical nursing experience required.
· One to two (1–2) years of clinical research coordination experience preferred.
· Experience in nephrology, chronic kidney disease (CKD), dialysis, or a related therapeutic area preferred.
· Current Basic Life Support (BLS) certification required; ACLS preferred.
· Clinical research certification (e.g., CCRC or CCRP) preferred, or willingness to obtain within a defined period.
Skills & Competencies
· Working knowledge of Good Clinical Practice (GCP), ICH guidelines, and FDA regulations.
· Phlebotomy, specimen processing, and IV/venipuncture competency.
· Proficiency with electronic medical record (EMR) and electronic data capture (EDC) systems.
· Strong organizational, documentation, and time-management skills.
· Excellent interpersonal and communication skills, with a participant-centered approach.
· Ability to manage multiple studies and competing priorities with strong attention to detail.
Pay: $80,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
