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Principal Investigator

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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.

Qualifications

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.

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Average salary estimate

$125000 / YEARLY (est.)

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$100000K

$150000K

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What You Should Know About Principal Investigator, Celerion

Celerion is looking for a dedicated Principal Investigator to join our team in Lincoln, NE, where we’re committed to fast-tracking clinical research through innovative strategies. As a Principal Investigator, you’ll play a crucial role in ensuring the safety of participants involved in clinical trials while executing studies in accordance with IRB-approved protocols and the strict regulations of the FDA and GCP. From the pre-study phase, where you’ll review protocols and provide valuable insights to sponsors, to the active management of the trial, your expertise will guide the compassionate and ethical treatment of our subjects. You’ll perform physical exams, handle the clinical evaluation of subjects, and navigate any adverse events that arise—always with a keen eye for safety and detail. After conducting a thorough review of all data, you’ll finalize clinical study reports and present findings to sponsors, showcasing Celerion’s exceptional capabilities. With your MD or DO degree, relevant certifications, and a blend of medical and clinical research experience, you’re poised to ensure our research is not only effective but also conducted with the utmost integrity and respect for participants. If you’re ready to make a significant impact in the world of clinical trials, Celerion would love to have you on our team.

Frequently Asked Questions (FAQs) for Principal Investigator Role at Celerion

What are the key responsibilities of the Principal Investigator at Celerion?

The Principal Investigator at Celerion is responsible for participant safety and the overall execution of clinical trials. This includes reviewing protocols, managing adverse events, conducting physical exams, and ensuring compliance with FDA and GCP regulations. Additionally, the PI collaborates with sponsors and the Institutional Review Board to maintain safety and integrity throughout the study.