Regulatory Specialist
Flourish Research
Summary
To create, maintain and coordinate regulatory documents and activities throughout clinical research studies conducted by a Flourish Research site according to SOPs, policies and procedures, applicable federal regulations, medical ethics, ICH, GCPs, IRB requirements, and in compliance with specific sponsor protocol requirements. To work closely with site leadership, principal investigators, and site staff. To collaborate with Sponsors, CROs, and IRB staff. Role functions begin at the time of study start-up, continuing through the duration of the trial, and until after study is deemed closed.
Job description
A Regulatory Specialist will be primarily focused on study start-up, delegation and training. We are seeing increased complexity and volume of protocol start-up requirements and regulatory tasks. We need additional on-site support to drive start-up processes. Timely delegation and training staff are critical to our site meeting revenue goals for the ROY and maintaining quality.
Essential Job Functions
- 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 appropriate regulatory repositories
- Assist in and manage the archival of clinical trial documents/records
- Prepare for monitoring visits and audits
- Distribution, collection, processing, and tracking of Essential Site Regulatory Documents for all ongoing studies, including collection of updated Investigator, Pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates, as applicable
- Maintain confidentiality of study protocol information and Protected Health Information (PHI)
- Create error-free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.)
- Perform all duties in a safe and prudent manner
- Perform all study related duties in a time-and-cost effective manner in adherence with Flourish policies
- Represent Flourish Research in a professional and courteous manner when interacting with staff, sponsors, CROs, IRBs, participants, nursing and medical staff members of various clinics, hospitals and physician's offices
- Additional duties as assigned by management
Physical Requirements and/or Environmental Factors
- Work is normally performed in a typical interior clinical/office work environment
- Local travel may be required
- Ability to sit for extended amounts of time
- Ability to work in a call center environment with occasional distractions and noise
- Extensive computer use
- Occasional evening and weekend work schedules
- Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
- Ability to drive and daily availability of an automobile
Requirements
- High School Diploma or equivalence
- College degree preferred
- 0-3+ years' experience within the field of clinical or biological research
- Must be experienced with Microsoft Office applications (Outlook, Word and Excel)
- Experience with a CTMS system, eRegs/eDocs, and other internet-based platforms
- Must be detail oriented, organized, self-motivated
- Able to work independently and on a team
- Ability to stay on task and meet deadlines
- Must possess excellent interpersonal skills including written and verbal communications
- Moral and ethical in decision-making
- Good critical thinking and problem-solving skills
- Must be professional and have a strong work ethic
- Ability to adapt and take on additional tasks as requested
- Ability to problem solve while working closely across departments
- Excellent computer skills to include Office365 products
Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k) 100% match first 4%
- Tuition Reimbursement
- Parental Leave
- Employee Referral Program
- Employee Assistance Program
- Life Insurance
- Disability Insurance
- Generous PTO
- 8 Paid Holidays
Company overview
Flourish Research is a leading multi-site clinical trial organization with a national footprint across the United States. Founded in 2021 and headquartered in Apex, North Carolina, the company operates as a fully integrated clinical trial organization that acquires and operates best-in-class research sites. With over 20 locations nationwide, Flourish Research specializes in three main therapeutic areas: Neuroscience (including Alzheimer's disease research), Infectious Diseases (with significant contributions to COVID-19 vaccine development), and Cardiovascular/Metabolic/Kidney disorders. The company provides comprehensive clinical trial services from Phase I to Phase IV studies, featuring early-phase inpatient units, AI-assisted patient recruitment, and site start-up support. Flourish Research is recognized for its commitment to patient diversity, high retention rates, and quality data delivery, having completed over 5,500 successful trials with 400,000 potential participants. The organization emphasizes physician-led research models and maintains strategic partnerships with pharmaceutical and biotech sponsors to accelerate the development of innovative treatments for unmet medical needs.