Clinical Research Sub-Investigator / Principal Investigator
On-siteChicago, Illinois, United States
Job Summary
Conduct assigned clinical studies in accordance with protocols, FDA regulations, and Good Clinical Practice standards while screening, evaluating, and monitoring prospective study volunteers. Perform physical exams, obtain informed consent, order diagnostic tests, and manage acute or non-acute clinical issues, promptly reporting adverse events to the sponsor, IRB, and FDA as required. Maintain accurate source documentation, case report forms, and progress notes to ensure audit readiness, while collaborating with study coordinators, research nurses, and sponsor representatives to execute trial activities. For Principal Investigators, hold ultimate regulatory and medical responsibility, oversee delegated staff, and sign required regulatory documents. Schedule is Monday–Friday, full-time, on-site at the Chicago research center with no nights, weekends, or on-call rotation.
Required Qualifications
- Active, unrestricted Illinois medical license (MD or DO) with ability to obtain
- Active, unrestricted Illinois license for MD, DO, NP, or PA
- Proficiency with Microsoft Office
- Ability to lift/move up to 50 lbs
- Ability to stand/walk for extended periods
- Ability to handle biological materials as required by lab procedures
- Full-time, on-site schedule at Chicago research center
- Monday–Friday schedule
- No nights, weekends, or on-call rotation
- Working knowledge of FDA regulations
- Working knowledge of ICH-GCP
- Working knowledge of IRB processes
- Excellent written and verbal communication skills
- Comfort performing physical exams
- Drawing on clinical judgment for acute/non-acute issues
- Working within a protocol-driven environment
- Willingness to complete GCP certification
- Willingness to complete sponsor-required training
- Ability to learn clinical trial management (CTMS) systems
- Ability to learn electronic data capture (EDC) systems
- Ability to obtain active, unrestricted Illinois medical license
Desired Qualifications
- Board certification in relevant specialty
- Prior clinical research experience
- Strong clinical/patient-care backgrounds
- 5+ years of clinical research experience as a PI or Sub-Investigator
- Prior PI experience
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