Regulatory Compliance Specialist

About Us: Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status.

We are actively hiring a Regulatory Compliance Specialist.

The Role

Prepare, maintain and provide oversight to all research-related regulatory documents. Populate and coordinate the entire process of initial regulatory documents’ submission to the IRB, sponsors and state or federal regulatory offices as necessary.

• Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor.
• Prepare applicable submission forms and submit updated documents including but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s and informed consent documents.
• Accurately file and maintain all necessary logs within the regulatory binder(s).
• Assist in and manage the archival of clinical trial documents/records.
• Prepare for monitoring visits and audits.
• Manage and update full-time and contract employee Curricula Vitae and ensure copies of all current and applicable medical/nursing licenses, certifications and other required regulatory documents are on file.
• Abide by all HIPAA regulations.
• Maintain confidentiality of sponsor and CTT trade secrets.
• Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
• Seek additional assignments when other tasks are completed.
• Perform all duties in a time- and cost-effective manner.
• Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
• Additional duties as assigned by management.

Requirements

Minimum Requirements:

• Bachelor’s degree or equivalent experience
• Minimum of 2+ years at CTT plus 3 years’ experience within the field of clinical or biological research.

Knowledge and Skills:

• Exceptional knowledge of clinical research methods.
• Consistently demonstrates core values & proficiency of skills set.
• Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
• Must be detail oriented, organized, self-motivated, be able to work independently and one team, and the ability to stay on task.
• Demonstrates excellent interpersonal skills including written and verbal communications.

Benefits

Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, employee referral program, employee assistance program, life insurance, disability insurance, and a generous PTO plan covering vacation, sick, personal days and 8 paid holidays.