Celerion

Global CRO for early-phase development

Principal Investigator

Physicians & SurgeonsConfirmed live in the last 24 hours

Full-timeLincoln, NE, USANo salary listedIn-person

About the Job

Requirements

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

Responsibilities

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.
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.
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.

Desired Qualifications

3-5 years of medical/clinical experience preferred
Clinical research experience preferred

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

If you are a Gmail user and you chose to receive e-mails from @celerion.com, please check your Spam folder regarding the status of your application, including requests for availability and interview invitations. Additionally, ensure you mark Celerion e-mails as “Not Junk”.

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.

Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations. If you find one there, mark it as "Not Junk" to ensure future Celerion emails land in your inbox. Please note that Gmail accounts have been particularly noted as routing to Spam.

About the Company

Celerion

Global CRO for early-phase development

Celerion is a global contract research organization focused on early-phase drug development. It conducts contracted research across clinical trial design, feasibility studies, project management, clinical and medical monitoring, bioanalytical sciences, and regulatory affairs, using High Resolution Mass Spectrometry-based metabolite profiling to inform decisions. Its advantage comes from over 40 years of experience, specialized metabolite profiling, and a global, integrated service model that accelerates development timelines. The goal is to help pharmaceutical and biotech clients bring safe and effective treatments to patients faster through rigorous, high-quality research.

Company size: 1,001-5,000
Company stage: Acquired
Total funding: Not listed
Headquarters: Lincoln, NE
Founded: 2010

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