Regulatory Specialist

Purpose

To create, maintain and coordinate regulatory documents and activities throughout clinical research studies conducted by a Flourish Research site according to Flourish Research's SOPs, policies and procedures, applicable federal regulations, medical ethics, International Council of Harmonization (ICH), Good Clinical Practices (GCPs), Institutional Review Board (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.

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, and medical staff.
• 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.

Education

High School Diploma, or equivalence. College degree preferred; however, is not required.

Experience

0-3+ years' experience within the field of clinical or biological research.

Knowledge and Skills

• Demonstrates core values and all skills set required.
• Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as a CTMS system, eRegs/eDocs, and other internet-based platforms.
• Must be detail oriented, organized, self-motivated, be able to work independently and on a team, as well as the ability to stay on task and meet deadlines.
• Must possess excellent interpersonal skills including written and verbal communications.
• Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite sites and other employees.
• Must have good critical thinking and problem-solving skills.
• Must be professional and have a strong work ethic.
• Must have the ability to adapt and take on additional tasks as requested.
• Ability to problem solve while working closely across departments.
• Assists with key initiatives/process improvements in the department.
• Assists with training company new hires.
• Completes at least 80% of goals annually.
• Excellent computer skills to include Office365 products.