Sub-Investigator - APRN/PA

Position Overview

The Sub-Investigator (Sub-I) supports the Principal Investigator (PI) in the safe and compliant conduct of clinical trials. This role is responsible for performing study-related medical procedures, ensuring protocol adherence, protecting subject safety, and maintaining high standards of data integrity in accordance with Good Clinical Practice (GCP), FDA regulations, and study-specific requirements.

The Sub-I plays a critical role and must be able to independently assess subjects, make medical decisions, and support clinical conduct of study execution in collaboration with the PI and clinical operations team.

Role and Responsibilities

Clinical Oversight & Patient Care

• Perform study-specific clinical assessments and evaluations (e.g., physical exams, medical history review, AE/SAE assessment)
• Determine subject eligibility in accordance with protocol inclusion/exclusion criteria
• Provide medical care and clinical assessment for enrolled subjects throughout study participation, as delegated by the PI
• Review and sign off on clinical data, source documentation, and study-related assessments as delegated
• Ensure subject safety, rights, and well-being are always prioritized
• Maintain availability aligned with study scheduled, subject visits, and sponsor expectations

Protocol & Regulatory Compliance

• Perform all study activities in adherence to the Delegation of Authority Log (DOA), protocol, GCP guidelines, and FDA regulations
• Maintain up-to-date knowledge of study protocols, IBs, and sponsor requirements
• Support informed consent process, ensuring subjects understand risks, benefits, and study expectations
• Review and assess adverse events (AEs) and serious adverse events (SAEs), ensuring appropriate documentation, escalation, and reporting timelines
• Participate in audits, monitoring visits, and regulatory inspections
• Collaborate with Clinical Operations, Recruitment, Coordinators, Quality Control, and Regulatory teams to ensure efficient and compliant study conduct

Data Integrity & Documentation

• Ensure accuracy, completeness, and timeliness of source documentation, ensuring adherence to GCP and ALCOA-C principles
• Review and resolve queries in collaboration with study coordinators and QC teams
• Ensure that documentation meets audit-ready standards and aligns with BWCS SOPs

Qualifications & Requirements

• MD, DO, NP, or PA with active, unrestricted license in applicable state(s)
• Prior experience as an Investigator in clinical research strongly preferred
• Strong understanding of GCP, FDA, and IRB regulations
• Current GCP certification (or willingness to complete training during onboarding)
• DEA license (if applicable to study requirements)

Preferred Skills:

• Strong clinical judgment and ability to make independent medical decisions
• High attention to detail with focus on data integrity and compliance
• Ability to interpret clinical protocols and apply in real-world settings
• Excellent communication and collaboration skills across multidisciplinary teams
• Experience with eSource, EDC systems, and clinical trial documentation
• Strong time management and ability to manage competing priorities

Additional Notes:

• This role requires timely availability for subject visits and sponsor expectations
• Must remain in good standing with licensing and credentialing requirements

Salary : $65 - $90