Principal Investigator - Family/Internal Medicine

Be Well Clinical Studies•Omaha, NE

1d•Onsite

About The Position

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.

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)

Nice To Haves

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

Responsibilities

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
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
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
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
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