Clinical Research Regulatory Coordinator - Cerritos, United States - Oncology Institute Inc.

Description

Regulatory CoordinatorThis is a fantastic opportunity to join a team of quality-oriented professionals focused on Clinical Research in Cerritos, CA

Responsibilities:
Maintains research practices using Good Clinical Practice (GCP) guidelines.
M aintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
H andle confidential material with judgement and discretionE-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 IBs, 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 year s experience with regulatory documen ts.

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.#J-18808-Ljbffr