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Temporary Regulatory Coordinator
1 week ago
Temporary Regulatory Coordinator - Cerritos, CA
Pay: $23 - $28/hour
Hours: Monday - Friday, 8am-5pm
Overview:
This is a 6 month, temporary position with an oncology research site in Cerritos, CA.
Responsibilities:
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
- Handle confidential material with judgement and discretion
- E-filing and sorting from DocuSign to Trial folders on G-drive.
- Reviews ICF completion, to verify documentation completed properly.
- Releases ICF due to requests from Study Coordinator.
- Prepares and releases documentation for training for New Amendments, New IB’s, Protocol Letters and or clarifications among other training document preparation.
- Documents research staff and investigators initial participation on trial and releases documents.
- Tracks and logs pending documents efficiently.
- Request Certification for new research staff and Investigators.
Education and Experience:
- Associates Degree or one or more (1+) years experience with regulatory documents.
- Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).
- Demonstrated experience with multi-study and multi-site clinical research activities.
- Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
- Demonstrated knowledge of FDA and Sponsor regulatory requirements.
- Knowledgeable of FDA and QA audit processes.
Skills:
- Associates Degree or one or more (1+) years experience with regulatory documents.
- Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
- Demonstrated knowledge of FDA and Sponsor regulatory requirements.
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