Regulatory Coordinator Position Available In Orange, Florida

Job Title:

Regulatory Coordinator Job Description Coordinate with the Regulatory Manager regarding regulatory and compliance practices. Under the supervision of the Regulatory Manager, the Regulatory Associate is responsible for gathering, assembling, maintaining, and storing complete and accurate essential documentation required for clinical studies. The Regulatory Associate is also responsible for tracking changes in regulatory guidelines as they may occur. Responsibilities Maintain required documentation for clinical studies at the site, and ensure GCP and FDA compliance. Obtain and store required clinical study documentation for each study. Review, process, and communicate data associated with essential document binders. Record, organize, and maintain necessary study data, study correspondence, and applicable logs. Flag problems and issues, track IRB and/or sponsor approvals, renewals, and correspondence. Draft required reports. Assist in preparing updates on SOPs, regulations, and guidelines for distribution to company personnel. Review study correspondence and reports for compliance. Assist in the maintenance of the document control system. Participate in interactions with Ethics Review Boards, Sponsors, CROs, and staff. Assist with submission preparation. Assist with regulatory document control. Prepare draft study documents (informed consents, phone screens, etc.) and assemble and review various documents (e.g., FDA Form 1572, CVs, Lab Certifications) in preparation for study submission. Organize, file, and maintain created and received study documents and correspondence in the appropriate sections of the regulatory binder. Type or fax letters, memoranda, or other correspondence. Work on several projects at once while balancing multiple timelines. Essential Skills Bachelor’s Degree in Healthcare or a minimum of a two-year degree. Experience in regulatory compliance, clinical research, and working with Institutional Review Boards. Strong computer and communication skills. Additional Skills & Qualifications Experience as a medical assistant. Ability to work on multiple projects with overlapping timelines. Work Environment This is a full-time position (40 hours a week) with shifts from Monday through Friday, 8:00 am – 5:00 pm, including a one-hour unpaid lunch break. The role involves heavy administrative work and the use of an individual office. The workplace is a 24/7 phase 1 clinical research facility.