Principal Investigator (Clinical Research)

Location: Lincoln, Nebraska, United States; onsite

Company

hirify.global conducts clinical research using translational medicine, clinical research expertise, and innovative study strategies.

What you will do

• Take responsibility for the safety of subjects participating in clinical trials and execute studies according to IRB-approved protocols, FDA regulations, and GCP requirements.
• Review protocols and Investigator Brochures, assess study feasibility, complete FDA 1572 and financial disclosure forms, and participate in study initiation meetings.
• Explain studies to subjects, answer questions, obtain informed consent, conduct screening examinations, and authorize eligible subjects for enrollment.
• Perform scheduled and adverse-event-related physical examinations, evaluate clinical findings, review laboratory results and ECGs, and determine appropriate safety actions.
• Prepare and review safety reports, serious adverse event and SUSAR submissions, case report forms, and final clinical study reports within required timelines.
• Support sponsor meetings, specialist networks, study design, SOP and training development, emergency response training, and site safety procedures.

Requirements

• Clinical research and clinical trial experience with responsibility for participant safety.
• Knowledge of FDA and GCP regulations, IRB processes, informed consent, and clinical study protocols.
• Ability to conduct physical examinations and evaluate laboratory results, ECGs, adverse events, and other clinical data.
• Ability to complete and review regulatory and clinical documentation, including FDA 1572 forms, case report forms, and safety reports.
• Ability to work onsite in Lincoln, Nebraska, United States.

Culture & Benefits

• Work environment centered on integrity, trust, teamwork, and respect.
• Opportunity to contribute to translational medicine and accelerate drug development through clinical research.
• Equal opportunity employment.