Lead Clinical Investigator - Flexible Schedule

Celerion; Lincoln (NE); On-site; USD 120,000 - 190,000; Full time

Job summary

Celerion is seeking a qualified Principal Investigator to oversee safety and conduct of clinical trials in line with FDA, GCP, and IRB requirements. The PI ensures subject safety, protocol adherence, and accurate data collection during all study phases.

Responsibilities include protocol review, subject screening, SAE assessment, case report forms, safety reporting, and collaboration with sponsors and IRB. Candidates should have MD/DO, active license, and relevant clinical research experience,

Qualifications

• MD or DO degree and state medical license required.
• Basic Life Support and Advanced Cardiac Life Support certifications.
• Completed ACGME residency in family medicine, internal medicine, or emergency medicine.
• DEA certificate for schedule II medications is required or preferred.
• 3–5 years of medical/clinical experience.
• Clinical research experience preferred.
• Ability to work a flexible schedule.

Responsibilities

• Oversee safety of subjects in clinical trials and ensure protocol adherence according to FDA, GCP, and IRB requirements.
• Review protocol, investigator brochure, and informed consent; ensure proper screening and enrollment.
• Monitor adverse events, SAEs, and safety data; communicate with sponsor and IRB as needed.
• Prepare Case Report Forms and final Clinical Study Reports; sign off on data integrity.
• Assist on-site client review of Case Report Forms and study documentation.
• Assist in safety reporting and data review for end-of-study analyses.

Education

MD or DO degree

Current state license

Basic Life Support certification

Advanced Cardiac Life Support certification

ACGME residency in family/internal/emergency medicine

DEA certificate for schedule II medications

3–5 years medical/clinical experience

Clinical research experience

Flexible schedule

Job description

Celerion is seeking a qualified Principal Investigator to oversee safety and conduct of clinical trials in line with FDA, GCP, and IRB requirements. The PI ensures subject safety, protocol adherence, and accurate data collection during all study phases.

Responsibilities include protocol review, subject screening, SAE assessment, case report forms, safety reporting, and collaboration with sponsors and IRB. Candidates should have MD/DO, active license, and relevant clinical research experience,