Regulatory Compliance Specialist

Flourish Research

Regulatory Compliance Specialist preparing and overseeing regulatory documents for clinical trials at Flourish Research. Collaborating with teams and ensuring compliance with regulatory standards.

Posted 7/27/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $24 - $28 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research methods and regulatory compliance, with a strong ability to prepare and manage regulatory documents and submissions. Exhibits exceptional organizational skills and attention to detail while maintaining confidentiality and fostering professional relationships.

Highest-signal resume keywords

Clinical Research MethodsRegulatory Document ManagementMicrosoft Office ApplicationsInterpersonal Communication SkillsProblem-Solving Ability

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationIRB Submission CoordinationClinical Trial ArchivingReport CompilationData Management

Soft Skills

Detail OrientedSelf-MotivatedOrganizational SkillsCritical ThinkingTeam Collaboration

Tools & Technologies

Microsoft OutlookMicrosoft WordMicrosoft ExcelInternet-Based Applications

Certifications & Qualifications

Industry Certification

Industry Keywords

HIPAA RegulationsClinical ResearchBiological ResearchRegulatory ComplianceSponsor Interaction

About the role

Key responsibilities & impact

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 regulatory binder(s).
Assist in and manage the archival of clinical trial documents/records.
Prepare for monitoring visits and audits.
Manage and update full-time and contract employee Curricula Vitae and ensure copies of all current and applicable medical/nursing licenses, certifications and other required regulatory documents are on file.
Abide by all HIPAA regulations.
Maintain confidentiality of sponsor and Flourish trade secrets.
Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
Seek additional assignments when other tasks are completed.
Perform all duties in a time- and cost-effective manner.
Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
Additional duties as assigned by management.

Requirements

What you’ll need

Bachelor’s degree or equivalent experience
Minimum of 3 years’ experience within the field of clinical or biological research.
Exceptional knowledge of clinical research methods.
Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
Must be detail oriented, organized, self-motivated, be able to work independently and one team, and the ability to stay on task.
Demonstrates 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 clinics and other employees.
Must have the ability to adapt and take on additional tasks as requested.
Ability to solve problems while working closely across departments.
Assists with developing and implementing key initiatives in the department.
Assists with identifying and implementing process improvements.
Seeks out opportunities to help achieve department/company goals.
Fosters relationships across teams.
Consistently accomplishes 80% of individual quarterly goals and objectives.
Assists with training and mentoring department new hires.
Demonstrates good critical thinking and decision-making skills resulting in sound judgement.
Industry certified as applicable.
Demonstrated ability to collaborate and align with operations.
Flexible and able to multi-task and prioritize competing demands.
Ability to think independently and influence when appropriate.

Benefits

Comp & perks

Health, dental, and vision insurance plans
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.