Principal Investigator

Job Title: Principal Investigator

Location: Nebraska 

Position Summary

The Principal Investigator (PI) holds primary responsibility for the clinical integrity, subject safety, and regulatory compliance of studies conducted at the site. The PI ensures trials are conducted in alignment with approved protocols, ethical standards, and all relevant regulatory requirements (e.g., FDA, ICH-GCP).

Key Responsibilities

Before Study Start:

• Analyze the clinical protocol and Investigator Brochure to ensure the study is scientifically sound, operationally feasible, and safe for participants.
• Offer medical insights to sponsors as needed during study planning.
• Complete and sign required regulatory forms, including FDA Form 1572 and financial disclosure documentation.
• Participate in investigator meetings and study initiation briefings.
• Collaborate with ethics committees to support protocol submissions and resolve safety-related queries.
• Educate and consent study participants, ensuring informed consent is obtained properly.
• Perform initial medical assessments and confirm subject eligibility for enrollment.

Study Conduct & Close-Out:

• Conduct physical exams at protocol-defined intervals and as clinically indicated during adverse events.
• Evaluate clinical findings and determine causality and severity of adverse events in relation to investigational products.
• Monitor safety lab results, ECGs, and other diagnostic data to determine necessary actions; communicate safety concerns with the sponsor team.
• Draft or review safety reports and serious adverse event (SAE) documentation in accordance with reporting timelines.
• Review, verify, and sign off on Case Report Forms (CRFs) and final study reports.
• Ensure timely communication of serious adverse events and suspected unexpected serious adverse reactions (SUSARs) to the appropriate bodies.
• Conduct final data reviews to assess the need for follow-up assessments or repeat testing.
• Oversee final physical evaluations and ensure all unresolved safety issues are properly tracked and documented.

Site & Clinical Leadership:

• Assist in identifying and contracting with external medical experts for specialist input or study-related procedures.
• Represent the site and its capabilities during sponsor and partner meetings.
• Provide clinical input into study planning and procedure scheduling, especially for trials with complex designs.
• Serve as a clinical point of contact and advisor to the research team.
• Support the development of standard operating procedures (SOPs), training plans, and clinical safety protocols.
• Coordinate safety drills and ensure the site is prepared for emergency response situations.
• Advise on acquisition of medical equipment for specialized studies.
• May supervise medical or clinical staff, including training, mentoring, performance evaluation, and team development.

Requirements:

• Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO); active medical license (licensure support available for those relocating).
• Board Certification in Internal Medicine, Family Medicine or Primary Care preferred 
• DEA license to prescribe Schedule II substances.
• Basic and Advanced Cardiac Life Support (BLS & ACLS) certifications (or willingness to complete upon hire).
• Completion of an ACGME-accredited residency in a relevant specialty such as Internal Medicine, Family Medicine, or Emergency Medicine.
• At least 3 years of clinical practice; prior experience in clinical trials preferred.
• Bilingual English/Spanish skills are beneficial for certain locations 
• Must be open to working flexible hours, including early mornings or weekends, depending on protocol demands.

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