Principal Investigator

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 committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

The PI is responsible for the safety of subjects who participate in clinical trials and for executing the study according to the IRB-approved protocol and applicable FDA and GCP regulations.

Pre-Study:

• Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study. Provide input to sponsor as indicated.
• Complete FDA 1572 and financial disclosure forms.
• Attend study initiation meetings with sponsor.
• Communicate with Institutional Review Board during protocol approval process and subject safety issues.
• Explain study to subject and answer questions, ensure proper consent, and perform screening examination.
• Final review of all screening data and authorization of subjects to be enrolled in the study.

During/Post Study:

• Perform scheduled per protocol, and unscheduled per adverse event, physicals during study conduct.
• Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity, and etiology. Review pre-dose lab work, ECGs, and other study data and determine appropriate action plan based on these results. Review safety data with sponsor.
• Compose SAE and other reporting documents as indicated.
• Review and sign Case Report Forms and final Clinical Study Reports.
• Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines
• Data review of all end-of-study data to determine if re-checks are necessary
• Safety-monitoring – perform end-of-study physical exams and follow-up ongoing adverse events
• Case Report Forms review – review and sign all case report forms at end of study
• Assist in on-site client review of case report forms

Additional Responsibilities:

• Assist with identifying and maintaining a network of physician specialists to contract on studies.
• Present Celerion’s capabilities and experience during sponsor meetings and events.
• Assist in the design of study and time/event schedules involving special medical procedures
• Function as a medical/clinical informational resource for the site.
• Assist other departments with development of SOPs, training plans, etc.
• Facilitate emergency response training and review of clinical safety procedures.

• MD or DO degree and current state license.
• Basic Life Support and Advanced Cardiac Life Support certification
• Successful completion of an ACGME residency program in family medicine, internal medicine, or emergency medicine.
• Hold a DEA certificate for schedule II medications
• 3-5 years of medical/clinical experience preferred
• Clinical research experience preferred
• Able to work a flexible schedule

Celerion Values:

Integrity Trust Teamwork Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.