Proclinical is currently recruiting for a Regulatory Coordinator with a pharmaceutical company located in Sacramento, CA.
- Supports all aspects of regulatory compliance for assigned studies.
- Prepares regulatory documents, including descriptions of study and consent forms, for submission to the Institutional Review Board (IRB).
- Tracks sponsor amendment notifications and submits amended protocols, consent forms and other regulatory documents to the IRB.
- Report serious adverse events and reportable new information to the IRB in a timely manner according to federal, local and institutional guidelines.
- Processes timely submissions of continuing review documents to the IRB.
- Coordinates with study sponsors, investigators and the IRB to complete study closure activities.
- Maintains current knowledge of Federal, State and institutional guidelines and requirements governing research.
- Prepares for and participates in monitoring visits for clinical trials.
- Prepares for and participates in quality assurance audits conducted by the sponsor, FDA, NCI, Cancer Center Quality Assurance Committee or other specially designated groups when requested
Skills and Requirements:
- Knowledge and understanding of disease processes as applied to human clinical research.
- Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP]) is essential.
- Knowledge of regulatory processes as well as a working knowledge of data management activities as applied to clinical trial coordination.
- Knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
- Working knowledge with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.