Celerion Jobs

Principal Investigator

Celerion

Principal Investigator

Posted Yesterday

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Lincoln, NE, USA

In-Office

Mid level

Pharmaceutical

The Role

Responsible for subject safety and executing IRB-approved clinical trial protocols per FDA and GCP. Duties include pre-study review, consenting and screening subjects, conducting exams, managing and reporting adverse events/SAEs, reviewing CRFs and study data, coordinating with sponsors and IRB, designing study procedures, maintaining physician networks, and supporting SOPs, training, and emergency response.

Summary Generated by Built In

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.

Skills Required

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

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The Company

HQ: Lincoln, NE

1,029 Employees

Year Founded: 2010

What We Do

Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines. With over 50 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical proof-of-concept, cardiovascular safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. Our operations are strategically located in: Lincoln, Nebraska (Corporate Headquarters) Philadelphia, Pennsylvania Phoenix, Arizona Belfast, Northern Ireland,UK Zurich, Switzerland Vienna, Austria Richmond, Virginia Montreal, Quebec, Canada For more information, visit: www.celerion.com