Principal Investigator (MD/DO)

System One; Indianapolis (IN); On-site; USD 160,000 - 240,000; Full time

Benefits offered by this job

Health and welfare benefits

401(k) plan

Equal Opportunity Employer

Job summary

System One is seeking a Principal Investigator in Indianapolis, IN to lead medical oversight for clinical trials onsite. The role focuses on patient safety, data quality, and compliance with ICH-GCP and FDA regulations, collaborating with sponsors, CROs, and site staff.

The PI will review eligibility, oversee safety data, and guide team members while advancing clinical research programs and new therapies at the site level.

Qualifications

• MD/DO with Internal Medicine, Family Medicine, or Specialist background.
• Active, unrestricted Indiana medical license.
• Prior clinical research PI or related physician role experience.

Responsibilities

• Provide medical oversight and clinical leadership for trials, ensuring patient safety and data quality.
• Serve as study physician, review eligibility and screening outcomes.
• Review adverse events and safety trends.
• Perform or oversee study-specific medical assessments.
• Guide Sub-Investigators, Coordinators, RNs, and staff.
• Collaborate with sponsors, CROs, IRBs, and leadership.
• Participate in site initiation, monitoring, and close-out visits.
• Review clinical data such as labs, ECGs, vitals.
• Support safety reporting and clinical documentation.
• Maintain compliance with protocols, ICH-GCP, FDA regulations.
• Contribute to quality culture and patient-centered research.

Skills

Clinical judgment

Communication

Documentation

Confidentiality

Review of structured data

Education

MD/DO medical degree

Board certification

Job description

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.

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