Regulatory Specialist I Position Available In Orange, Florida
Tallo's Job Summary: The Regulatory Specialist I position involves preparing and submitting research protocols, maintaining regulatory documents, and ensuring compliance with Federal regulations and guidelines. The role requires a minimum of 1 year of clinical research experience and certification through professional research organizations. A healthcare-related associate degree or equivalent work experience is required, with a bachelor's degree preferred. AHRI is recruiting for this position.
Job Description
Regulatory Specialist I Key Responsibilities:
Prepare and submit new research protocols, amendments, continuing reviews, and investigational product updates. Ensure completeness and accuracy of documents while meeting submission deadlines. Prepare and submit informed consent documents and revisions, ensuring all languages requested by the study team are reviewed and approved. Maintain regulatory documents in compliance with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and AHRI policies. Monitor review, approval, and clearance activities for each research protocol, maintaining detailed records. Assist in sponsor monitoring visits and ensure proper access to eRegulatory files. Disseminate regulatory communications and study updates to facilitate protocol adherence, patient safety, and regulatory compliance. Archive regulatory documents for closed studies per regulatory retention periods. Maintain the Research Personnel Log, ensuring timely updates of CVs, licenses, certifications, and mandatory training documentation. Communicate with the COI office regarding Management Plans and ensure protocol registration on ClinicalTrials.gov when required. Support internal and external auditing and monitoring needs. Qualifications MUST have a minimum of 1 year of experience in clinical research environment and regulatory document submission Certification through professional research organizations such as SOCRA, ACRP, SRA, or PRIM&R preferred
Minimum:
Associate degree in healthcare-related field or biological sciences; OR equivalent work experience in healthcare, clinical research, or scientific setting
Preferred:
Bachelor’s degree in healthcare, administration, or research-related field
