Principal Investigator Actalent
Overview
Lead and oversee clinical investigation protocols ensuring FDA regulations and GCP/ICH guidelines compliance. Manage medical care of research subjects protecting rights and welfare while ensuring validity and documentation of trial data. Complete required training including GCP and IATA. Maintain up-to-date curriculum vitae and licensure. Assume responsibility for clinical investigation protocols. Understand protocol requirements and determine adequate resources for research.
What You'll Do15
- 1Complete required training including GCP and IATA
- 2Maintain working knowledge of FDA regulations GCP/ICH guidelines SOPs and study protocols
- 3Keep current curriculum vitae and licensure
- 4Assume responsibility for clinical investigation protocols
- 5Understand protocol requirements and determine resources for research
- 6Manage medical care of subjects and protect their rights and welfare
- 7Ensure validity of trial data reported to sponsors
- 8Document study-related procedures processes and events
- 9Ensure proper use and storage of investigational products
- 10Attend investigator meetings as needed
- 11Assist with creating PI oversight plans for studies
- 12Conduct and oversee staff training
- 13Conduct patient consent discussions ensuring understanding of procedures risks benefits and alternatives
- 14Provide clear explanations of study protocols and ensure patient understanding before consent
- 15Facilitate effective communication between patients healthcare providers and research staff
Requirements7
- 15+ years building ETL pipelines with Spark and Airflow
- 2Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) with active license
- 3Compliance with clinical trial regulations
- 4Board certification or eligibility in relevant specialty
- 5Training and certification in SOPs and Good Clinical Practice (GCP)
- 6Minimum of 1 year clinical research experience preferably in general medicine or complex therapeutic areas
- 7Experience with Phase I clinical trials
Salary Insight
$270 - $312k per year
Location
Required Skills
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