Principal Investigator - Family/Internal Medicine

Pay: Individual contracted rate per study serving as PI / $100/hr for general or Sub-I specific work

Position Overview

The Principal Investigator (PI) is responsible for the overall conduct, oversight, and integrity of clinical trials conducted at the site. The PI assumes ultimate responsibility for subject safety, regulatory compliance, protocol adherence, and data integrity in accordance with ICH-GCP, FDA regulations, IRB requirements, and sponsor protocols.

The PI provides medical and scientific leadership, ensures adequate supervision of delegated study personnel, and maintains full accountability for all trial-related activities, regardless of delegation.

Role and Responsibilities

Clinical Oversight & Subject Safety

• Provide overall medical oversight for all studies conducted under their supervision
• Ensure subject safety, rights, and welfare are protected at all times
• Review, assess, and provide medical oversight for:
  • Subject eligibility determinations
  • Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Protocol-related clinical decision-making
• Be available to address clinical issues and safety concerns in real time
• Ensure appropriate medical care is provided to subjects for study-related needs

Regulatory & Compliance Oversight

• Maintain ultimate responsibility for compliance with:
  • Approved protocol(s)
  • ICH-GCP guidelines
  • FDA regulations (21 CFR Parts 50, 54, 56, 312/812 as applicable)
  • IRB/IBC requirements
• Ensure all study activities are conducted per the Delegation of Authority Log (DOA)
• Provide oversight of delegated staff, ensuring qualifications, training, and compliance
• Review and approve protocol deviations and corrective actions
• Participate in and support Sponsor monitoring visits, audits, and regulatory inspections

Protocol Execution & Study Management

• Ensure the study is conducted in accordance with the approved protocol
• Confirm that study personnel are appropriately trained
• Oversee enrollment strategy and ensure ethical recruitment practices
• Maintain appropriate oversight of investigational product (if applicable)
• Support feasibility assessments and study start-up activities

Data Integrity & Documentation

• Ensure all study data is maintained in compliance with ALCOA-C principles
• Review and sign source documentation and eCRF/EDC entries
• Ensure timely resolution of queries
• Maintain audit-ready documentation at all times

Leadership & Team Oversight

• Provide direct oversight and supervision of Sub-Investigators, study staff, and protocol conduct
• Ensure clear delegation, training, and accountability across study roles
• Foster a culture of compliance, quality, and patient safety
• Collaborate cross-functionally with Clinical Operations, Compliance, Regulatory, Quality Control, and Recruitment teams

Qualifications & Requirements

• MD or DO with active, unrestricted medical license in applicable state
• Prior experience as a Principal Investigator strongly preferred
• Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, clinical trial processes
• Current GCP certification (or ability to obtain upon onboarding)
• DEA license (if required by study protocol)

Preferred Skills

• Strong clinical judgment and decision-making authority
• Proven ability to lead and oversee clinical research teams
• High level of accountability and regulatory awareness
• Strong documentation and audit-readiness mindset
• Experience with EDC, eSource, and clinical trial systems
• Excellent communication and leadership skills

Additional Notes

• The PI retains full responsibility for all study activities
• Must maintain current licensure, credentials, and training compliance
• Expected to maintain sufficient availability to meet study and regulatory obligations
• Must adhere to sponsor, protocol, IRB/IBC, and BWCS SOP requirements

Salary : $100