Regulatory Specialist I / Daytona Beach, FL (On-Site)

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.