Regulatory Specialist I

Flourish Research • Detroit, MI

6d • Hybrid

About The Position

Flourish Research is hiring a Regulatory Specialist I to support its Detroit, Michigan site. The role prepares, maintains, and oversees research-related regulatory documentation and coordinates submissions to institutional review boards (IRBs), sponsors, and applicable state or federal regulatory offices. The specialist compiles study information and submits initial, continuing, and final reports; prepares submissions and updated study documents; maintains regulatory logs and repositories; and assists with clinical trial document archival. The role also supports monitoring visits and audits and coordinates the collection, processing, distribution, and tracking of essential site regulatory documents for ongoing studies. The position requires maintaining confidentiality of protocol information and protected health information, producing accurate written materials, and representing Flourish Research professionally when interacting with internal and external stakeholders. Work is hybrid in Detroit, Monday through Friday on a 40-hour day-shift schedule. Local travel may be required, and occasional evening and weekend work may occur. The position is classified as non-exempt and pays $27 to $33 per hour, depending on experience.

Requirements

• High school diploma or equivalent.
• 0–3+ years of experience in clinical or biological research.
• Experience with Microsoft Office applications, including Outlook, Word, and Excel, as well as a CTMS system, eRegs/eDocs, and other internet-based platforms.
• Detail-oriented, organized, self-motivated, and able to work independently and as part of a team while staying on task and meeting deadlines.
• Excellent written and verbal communication and interpersonal skills.
• Ethical decision-making and interactions with patients, sponsors, IRB representatives, physicians, satellite-site staff, and coworkers.
• Good critical-thinking and problem-solving skills.
• Professionalism and a strong work ethic.
• Ability to adapt and take on additional tasks as requested.
• Ability to problem-solve while working across departments.
• Ability to sit for extended periods and work in a call center environment with occasional distractions and noise.
• Extensive computer use.
• Ability to properly lift 35 pounds and occasionally more than 35 pounds.
• Ability to drive and daily availability of an automobile.

Nice To Haves

• College degree preferred but not required.

Responsibilities

• Prepare, maintain, and provide oversight of research-related regulatory documents.
• Populate and coordinate initial regulatory document submissions to IRBs, 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 submission forms and submit updated documents, including amendments, addendums, Investigator’s Brochures, safety information, Form FDA 1572s, and informed consent documents.
• Accurately file and maintain required logs in appropriate regulatory repositories.
• Assist with and manage archival of clinical trial documents and records.
• Prepare for monitoring visits and audits.
• Distribute, collect, process, and track essential site regulatory documents for ongoing studies, including updated investigator, pharmacist, and nursing CVs, licenses, GCP, IATA, and training certificates, in paper and electronic files.
• Maintain confidentiality of study protocol information and protected health information (PHI).
• Create accurate written documents and reports, such as cover letters, notes-to-file, and memos.
• Perform duties safely, prudently, and in a time- and cost-effective manner in adherence with Flourish policies.
• Represent Flourish Research professionally and courteously in verbal and written interactions with staff, sponsors, CROs, IRBs, participants, clinical personnel, contract personnel, and others.
• Perform additional duties as assigned by management.
• Assist with departmental initiatives and process improvements.
• Assist with training company new hires.
• Complete at least 80% of annual goals.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 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
• Generous paid time off covering vacation, sick, and personal days
• Eight paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED