Regulatory Coordinator

• 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.