Job Description

Under the guidance and supervision of the Principal Investigator (PI) or medical director, the Nurse Practitioner/ Physician’s Assistant (Sub Investigator) ensures the integrity and quality of the clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and OMRC policies and procedures. This position is primarily responsible for the accurate completion of visit procedures and collection of information from study patients according to protocols, and for protecting the health, safety, and welfare of research participants. In addition, the NP/PA- Sub Investigator may also acts as study coordinator for 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
• Trained in phlebotomy
• 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
• Certification as a psychometric rater or willingness to be trained and certified

Additional Information

Benefits

• Competitive salary
• Advancement and career opportunities
• 401(k), 401(k) matching
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

All your information will be kept confidential according to EEO guidelines.

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