Clinical Research Physician
3 days ago
Celerion is committed to delivering exceptional clinical research through translational medicine. Our team of experts uses innovative research strategies to help bring drugs to market faster.
Key Responsibilities:- Ensure the safety of subjects participating in clinical trials and execute studies according to IRB-approved protocols and applicable FDA and GCP regulations.
- Review protocols and Investigator Brochures for subject safety, scientific, and operational feasibility, providing input to sponsors as needed.
- Complete FDA 1572 and financial disclosure forms, attend study initiation meetings with sponsors, and communicate with Institutional Review Boards during protocol approval processes.
- Explain studies to subjects, ensure proper consent, and perform screening examinations, finalizing reviews of all screening data and authorizing subjects to be enrolled in studies.
- Manage adverse events, clinical evaluations of subjects, and determine adverse event relationships to investigational products, reviewing pre-dose lab work, ECGs, and other study data to determine appropriate action plans.
- Compose SAE and other reporting documents, review and sign Case Report Forms and final Clinical Study Reports, and review all serious adverse events and SUSARs to sponsors and IRBs within statutory timelines.
- Assist in on-site client reviews of Case Report Forms, assist with identifying and maintaining networks of physician specialists to contract on studies, and present Celerion's capabilities and experience during sponsor meetings and events.
- Function as a medical/clinical informational resource for the site, assist other departments with development of SOPs, training plans, and 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.
- Bilingual English/Spanish preferred in AZ.
- Able to work a flexible schedule.
Integrity, Trust, Teamwork, Respect
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