Nurse Practitioner (NP) – Clinical Research Sub-Investigator

Prime Clinical Research
Location: On-Site
Employment Type: Full-Time or Part-Time
Department: Clinical Research Operations
Reports To: Principal Investigator and Medical Director

Prime Clinical Research is seeking an experienced Nurse Practitioner (NP) Sub-Investigator to support the conduct of clinical trials at our investigative site. This role works closely with the Principal Investigator and clinical research team to provide protocol-driven medical oversight, participant safety management, and high-quality clinical documentation. Clinical research experience is preferred but experienced Nurse Practitioners interested in transitioning into clinical research are encouraged to apply.

The NP Sub-Investigator plays an essential role in protecting participant safety while ensuring studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Responsibilities include participant eligibility assessments, informed consent participation, investigational product oversight, safety monitoring, and collaboration with study coordinators and sponsor teams.

This position is ideal for a Nurse Practitioner who enjoys combining clinical care with medical research and contributing to the development of new therapies.

What you will do

Clinical Trial Medical Oversight

• Conduct protocol-required medical evaluations including medical history review, targeted physical exams, and review of laboratory results, imaging, and ECGs
• Support participant eligibility determinations and document clinical rationale for inclusion or exclusion decisions
• Collaborate with the Principal Investigator on complex eligibility cases and clinical decision-making

Informed Consent and Participant Engagement

• Participate in the informed consent process and ensure participants understand study procedures, risks, and alternatives
• Support re-consent following protocol amendments when required
• Ensure participant rights, safety, and autonomy are maintained throughout the study

Safety Monitoring and Adverse Event Management

• Detect, assess, and manage adverse events and serious adverse events in accordance with protocol and regulatory requirements
• Initiate protocol-directed actions such as dose modifications, treatment holds, or discontinuations when necessary
• Provide appropriate clinical follow-up and ensure accurate safety documentation

Investigational Product and Medication Oversight

• Ensure investigational product prescribing, dosing, and administration follow protocol requirements
• Review concomitant medications for potential interactions or protocol restrictions
• Recognize and manage infusion or administration reactions in collaboration with the study team

Documentation and Data Quality

• Maintain timely, accurate source documentation aligned with ALCOA+ documentation standards
• Ensure clinical documentation supports Electronic Data Capture entries and regulatory requirements
• Collaborate with Study Coordinators to resolve data discrepancies and ensure documentation accuracy

Monitoring, Audits, and Compliance

• Participate in sponsor monitoring visits, audits, and regulatory inspections as required
• Support corrective and preventive action activities when needed
• Maintain inspection readiness through high-quality documentation and adherence to site SOPs

Team Collaboration and Leadership

• Work closely with Principal Investigators, Study Coordinators, research staff, and sponsor teams
• Support training and mentoring of research staff on clinical oversight and safety processes
• Promote patient-centered research practices and high standards of clinical care

Required Qualifications

• Active Nurse Practitioner license in the practicing jurisdiction
• Current national NP certification such as AANP or ANCC
• Clinical experience relevant to the therapeutic areas conducted at the site or ability to onboard quickly
• Knowledge of clinical trial protocols and participant safety management
• Strong documentation and clinical decision-making skills
• Current BLS or ACLS certification, as required by the site

Preferred Qualifications

• Previous experience as a Sub-Investigator in clinical research
• Knowledge of ICH Good Clinical Practice (GCP) and human subjects protections
• Experience working with clinical research systems or Electronic Data Capture platforms
• Experience participating in sponsor monitoring visits or regulatory inspections

Work Environment

• On-site clinical research environment supporting active clinical trials
• Collaboration with investigators, clinical research coordinators, and sponsor teams
• Combination of clinical assessments and documentation responsibilities

Why Prime Clinical Research

Prime Clinical Research partners with pharmaceutical companies, biotechnology organizations, and contract research organizations to conduct clinical trials that advance medical innovation and improve patient outcomes.

Our research teams are committed to maintaining the highest standards of patient safety, regulatory compliance, and research integrity while expanding access to emerging therapies.

Prime Clinical Research is an Equal Opportunity Employer.