Principal Investigator (MD/DO)

Job Title: Principal Investigator Location: Indianapolis, IN Type: Full-time Work Model: Onsite

Overview

If you're an Internal Medicine/Specialist Physician looking for a way to stay engaged in medicine, contribute to the advancement of new therapies, and have a meaningful role in building something new, we'd love to talk with you. This is an opportunity to bring your medical and clinical research expertise to a greater patient population and new clinical research site.

Responsibilities

• Provide medical oversight and clinical leadership for assigned clinical trials, ensuring patient safety and data quality.
• Serve as the study physician, reviewing participant eligibility and overseeing screening outcomes.
• Review adverse events (AEs), serious adverse events (SAEs), and participant safety trends.
• Perform or oversee study-specific medical assessments, including histories, physical exams, and endpoint assessments.
• Offer clinical guidance and oversight to Sub-Investigators, Clinical Research Coordinators, RNs, and site staff.
• Collaborate with study sponsors, CROs, IRBs, and company leadership throughout each trial.
• Participate in Site Initiation Visits, monitoring visits, close-out activities, and other study meetings.
• Review clinical data such as laboratory results, ECGs, vital signs, and other assessments.
• Support safety reporting, medical documentation, and clinical data query resolution.
• Maintain compliance with study protocols, SOPs, ICH-GCP, FDA regulations, and state requirements.
• Contribute to a culture of quality, continuous improvement, and patient-centered research.

Requirements

• MD or DO with a background in Internal Medicine, Family Medicine, or a Specialist.
• Active, unrestricted Indiana medical license.
• Prior clinical research experience as a Principal Investigator, Sub-Investigator, or other clinical research physician.
• Strong clinical judgment and commitment to participant safety.
• Interest in clinical research and advancing medical innovation.
• Ability to review structured clinical data and study-specific medical information.
• Strong communication, documentation, and confidentiality practices.
• Familiarity with ICH-GCP and FDA clinical research regulations.
• Board certification.
• DEA registration, if required by study protocols.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #568-Clinical