Nurse Practitioner or Physician Assistant

Job Description

Under the guidance and supervision of the Principal Investigator (PI) or Medical Director, the Nurse Practitioner/Physician’s Assistant (Sub‐Investigator) upholds the integrity and quality of clinical trials by ensuring all activities comply with federal, state, and local regulations, IRB approvals, and OMRC policies and procedures. This role is primarily responsible for accurately performing visit procedures and collecting patient data in accordance with study protocols, while safeguarding the health, safety, and welfare of research participants. Additionally, the NP/PA Sub‐Investigator may serve as Study Coordinator for select, limited studies.

Essential Duties and Responsibilities:

• Reviews, comprehends, and adheres to assigned study protocol.
• Assists trial Investigators in screening and review of potential study participants' eligibility.
• Conducts subject visits.
• Maintains case report forms, patient charts and documentation.
• Ensures that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
• Collects and enters data as necessary.
• Reviews lab results, imaging reports, and other study-specific reports.
• Completes required protocol training

Qualifications

Requirements:

• Master’s Degree required
• Licensed Nurse Practitioner/Physician Assistant
• At least 2 years of clinical research/ sub-investigator experience is strongly preferred. 
• Trained in phlebotomy
• Pediatrics experience preferred
• Sound knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs
• Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills
• Strong written and verbal communication skills
• Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams
• Strong computer skills in appropriate software and related company clinical systems is required