Regulatory Specialist I

Flourish Research

. Prepare, maintain, and provide oversight to research-related regulatory documents .

Posted 10/22/2026full-timeDetroit • Michigan • United StatesMid-LevelSenior💰 $27 - $33 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in preparing and maintaining regulatory documents for clinical trials, including submissions to IRBs and sponsors. Proficient in utilizing CTMS systems and Microsoft Office applications while ensuring compliance with ethical standards and confidentiality.

Highest-signal resume keywords

Regulatory Document PreparationClinical Trial Management System (CTMS)Microsoft Office ApplicationsGood Clinical Practice (GCP)Critical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document OversightSubmission to IRBsDocument Filing and MaintenanceReport CompilationInvestigator’s Brochure PreparationForm FDA 1572Informed Consent Document PreparationArchival of Clinical Trial DocumentsMonitoring Visit PreparationData Entry

Soft Skills

Detail OrientedSelf-MotivatedExcellent Communication SkillsProfessionalismProblem-Solving

Tools & Technologies

CTMS SystemERegs/eDocsOffice365Microsoft OutlookMicrosoft WordMicrosoft Excel

Certifications & Qualifications

Good Clinical Practice (GCP) CertificationIATA Certification

Industry Keywords

Clinical ResearchRegulatory ComplianceProtected Health Information (PHI)Clinical TrialsEthical Decision-Making

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Prepare, maintain, and provide oversight to research-related regulatory documents
Populate and coordinate initial regulatory document submissions to IRBs, sponsors, and state or federal regulatory offices
Compile study information and submit initial, continuing, and final reports to IRBs and/or sponsors
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 logs in 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
Collect 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, including cover letters, notes-to-file, and memos
Perform study-related duties safely, prudently, and cost-effectively in adherence with company policies
Represent Flourish Research professionally 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 assigned by management

Requirements

What you’ll need

High School Diploma, or equivalence
0-3+ years’ experience within the field of clinical or biological research
Experience with Microsoft Office applications (Outlook, Word and Excel)
Experience with a CTMS system, eRegs/eDocs, and other internet-based platforms
Detail oriented and organized
Self-motivated and able to work independently and on a team
Ability to stay on task and meet deadlines
Excellent written and verbal communication skills
Moral and ethical decision-making
Good critical thinking and problem-solving skills
Professionalism and strong work ethic
Ability to adapt and take on additional tasks
Ability to work closely across departments
Excellent computer skills, including Office365 products
Ability to sit for extended amounts of time
Ability to work in a call center environment with occasional distractions and noise
Extensive computer use
Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds
Ability to drive and daily availability of an automobile
Occasional evening and weekend work schedules

Benefits

Comp & perks

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 PTO plan covering vacation, sick, personal days and 8 paid holidays
Supportive and collaborative work environment
Endless growth opportunities