Regulatory Specialist I Daytona Beach Fl

**Job Overview:** As one of the largest Clinical Research Organizations in the world, we have four **Early Phase Clinical Research Units** in the UK and US. We are currently seeking a **Regulatory Specialist I,** to interact directly with our healthy volunteer participants while learning to read clinical research protocols and enjoy working in a fast-paced team-oriented environment. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.) This is a full-time, **office/clinic-based** job in **Daytona Beach, FL**. If you join us, you will work with some of the world´s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug. WHAT YOU WILL DO: Responsible for providing overall regulatory support to clients, staff, and maintaining regulatory and IRB records associated with clinical studies conducted in clinical pharmacology. **Other key responsibilities**: * Assist staff and clients regarding regulatory responsibilities, where appropriate. * Maintain accurate and complete regulatory documents for all clinical studies conducted in the division of clinical pharmacology. * Responsible for weekly filing of Study Master Files and document submission for Trial Master Files. * Assist with regulatory training for staff as needed. * Coordinate and maintain regular updating of Fortrea CRU personnel and consultant CVs. * Coordinate the completion and accuracy of the Staff Signature Sheet. * Be knowledgeable about regulatory and related clinical operations SOPs. * Facilitate Consent Form preparation for clinical studies that conform to current regulatory requirements and SOPs. Incorporate necessary medical information as provided by the Investigator’s Brochure/package insert, the Principal Investigator, the Study Manager and/orthe client. * Prepare regulatory documents and IRB submissions for all clinical studies. * Track and route all incoming and outgoing regulatory correspondence. * Track status of pending studies for IRB review. * Submit all required initial and revised study documents, including advertising, protocol, * Investigators Brochure, and Consent Forms for IRB approval throughout the course of the study. * Facilitate the tracking and reporting of all Unanticipated Problems and/or serious adverse events to the IRB. * Ensure Sponsor safety letters are submitted to the IRB, as appropriate. * Track, prepare and submit interim reports and final summaries to the IRB. * Oversee preparation of all closed study files for archiving in long-term storage. * Assist with implementation of and adherence to all components of quality programs. * Assist with maintenance of staff training records and ensure compliance with training programs. * Maintain exemplary client communication with regard to the consent form, and total IRB review and approval process. * Consult with clients with regard to consent form language. * Ensure all Study Master Files are maintained according to SOPs and regulatory requirements. * Ensure all Trial Master File documents are forwarded as appropriate. * Liaise with independent IRBs as required to schedule appropriate reviews and ensure all appropriate documents are prepared for submission. * Ensure appropriate follow-up with independent IRBs. * Assist Study Managers with all IRB communication. * Participate in, and contribute to, Regulatory Specialists teleconference meetings on a regular basis. * Submit monthly reports on IRB metrics, and/or other information, as requested. * All other duties as needed or assigned. **YOU NEED TO BRING…** * BS or BA in medical or related field. * Fortrea may consider relevant and equivalent experience in lieu of educational requirements. * 0-1 years related experience. * 0-2 Additional experience may be substituted for education requirements. The important thing for us is you are comfortable working in an environment that is: * **Fast paced**: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. * **Changing priorities constantly** asking you to prioritize and adapt on the spot. * **Teamwork** and **people skills** are essential for the study to run smoothly. * **Technology based**. We collect our data directly into an electronic environment. What do you get? * Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: * Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) * 401(K) * Paid time off (PTO) * Employee recognition awards * Multiple ERG’s (employee resource groups) **_Physical Requirements:_** * _Excellent command of written and spoken English._ * _Regularly required to sit._ * _Must be able to see, talk, and hear._ * _Must be able to use hands, fingers, and handle or touch objects, tools, or controls, including a computer keyboard for up to 6 hours per day._ * _Must be able to use telephone and FAX machine._ * _Overtime and weekend work as required._ * _Potential travel for cross-site support needs or training needs._ Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).