Regulatory Specialist I

Flourish Research•Detroit, MI

1d•$27 - $33•Hybrid

About The Position

Flourish Research is hiring a Regulatory Specialist I to support its Detroit, Michigan site. This role prepares, maintains, and oversees research-related regulatory documents and coordinates submissions to institutional review boards (IRBs), sponsors, and state or federal regulatory offices as needed. The specialist compiles study information and submits initial, continuing, and final reports, as well as prepares submission forms and updates documents such as amendments, investigator brochures, safety information, FDA Form 1572s, and informed consent documents. The role maintains regulatory logs and repositories, assists with clinical trial document archival, and prepares for monitoring visits and audits. It also coordinates the distribution, collection, processing, and tracking of essential site regulatory documents for ongoing studies, including current investigator, pharmacist, and nursing credentials and training records. The specialist must protect protocol information and protected health information, produce accurate written materials, and conduct work safely, efficiently, and professionally while interacting with site personnel, sponsors, CROs, IRBs, participants, and clinical staff. Additional duties may be assigned by management. The position is hybrid in Detroit, Michigan, with a Monday–Friday day shift of 40 hours per week. Compensation is $27–$33 per hour, depending on experience. Work is generally performed in a clinical or office environment, with local travel possibly required. Occasional evening and weekend work may be scheduled.

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.
Moral and 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.
Excellent computer skills, including Office365 products.
Ability to sit for extended periods, use a computer extensively, and work in a call-center environment with occasional distractions and noise.
Ability to properly lift 35 pounds and occasionally more than 35 pounds.
Ability to drive and daily availability of an automobile.
Local travel may be required.

Nice To Haves

College degree; not required.

Responsibilities

Prepare, maintain, and oversee 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 brochures, safety information, FDA Form 1572s, and informed consent documents.
Accurately file and maintain necessary logs in appropriate regulatory repositories.
Assist with and manage the 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 CVs, licenses, GCP, IATA, and training certificates, in paper and electronic files.
Maintain confidentiality of study protocol information and protected health information (PHI).
Create error-free written documents and reports, such as cover letters, notes-to-file, and memos.
Perform duties safely and prudently, and complete study-related work in a time- and cost-effective manner in accordance with Flourish policies.
Represent Flourish Research professionally and courteously when interacting with staff, sponsors, CROs, IRBs, participants, and clinical personnel.
Assist with departmental initiatives and process improvements.
Assist with training new company hires.
Perform additional duties as assigned by management.