Regulatory Compliance Specialist

About Flourish Research

Flourish Research is a leading clinical trial organization with expertise in cardiology, metabolic disorders, nephrology, oncology, CNS, pulmonology, and vaccine research. We are dedicated to providing exceptional care to all individuals, embracing diversity across all dimensions including race, gender identity, religion, ethnicity, and more. Our commitment is to fostering an inclusive, respectful work environment that values unique perspectives and ideas to better serve our communities.

Position Overview

We are seeking a detail-oriented Regulatory Compliance Specialist to join our remote team. This full-time role requires working Monday through Friday on day shifts (40 hours per week) and is classified as non-exempt. Compensation ranges from $24 to $28 per hour.

Key Responsibilities

• Prepare, manage, and oversee all regulatory documentation related to research activities.
• Coordinate and submit initial regulatory documents to Institutional Review Boards (IRBs), sponsors, and relevant federal or state regulatory agencies.
• Compile and submit study-related reports including initial, ongoing, and final submissions to IRBs and sponsors.
• Prepare and update required submission forms such as amendments, addendums, Investigator's Brochures, safety reports, Form FDA 1572, and informed consent forms.
• Maintain accurate and organized regulatory binders and logs.
• Support the archiving of clinical trial documents and records.
• Assist with preparations for monitoring visits and audits.
• Manage and update curricula vitae for full-time and contract staff, ensuring all necessary licenses and certifications are current and documented.
• Ensure adherence to HIPAA regulations and maintain confidentiality of sensitive sponsor and company information.
• Produce error-free written correspondence, including cover letters, notes-to-file, and memos.
• Proactively seek additional assignments and complete tasks efficiently and cost-effectively.
• Represent Flourish Research professionally in all interactions with colleagues, clients, and vendors.
• Perform other duties as assigned by management.

Requirements

• Bachelor's degree or equivalent relevant experience.
• At least two years of clinical trial coordination experience plus one to three years in clinical or biological research.
• Strong understanding of clinical research methodologies.
• Proficiency in Microsoft Office (Word, Excel, Outlook) and internet-based applications.
• Exceptional attention to detail, organizational skills, self-motivation, and capability to work independently and collaboratively.
• Excellent interpersonal, written, and verbal communication skills.
• Ethical conduct and sound decision-making in interactions with patients, sponsors, IRBs, healthcare providers, and coworkers.
• Professional demeanor and strong work ethic.
• Ability to adapt to additional tasks and solve problems across departments.
• Experience supporting departmental initiatives and process improvements.
• Commitment to achieving individual quarterly goals at a minimum of 80% completion.
• Ability to mentor and train new department staff.
• Critical thinking skills that support sound judgment and decision-making.
• Relevant industry certification preferred.
• Ability to collaborate effectively and align with operations teams.
• Flexibility to manage multiple priorities and competing deadlines.
• Transportation and local travel availability, including a valid driver’s license and automobile.
• Ability to lift up to 25 pounds, occasionally more.
• Availability for occasional evening and weekend work.

Employee Benefits

• Health, dental, and vision insurance plans.
• 401(k) plan with 100% employer match on the first 4% of contributions.
• Tuition reimbursement programs.
• Parental leave benefits.
• Employee referral incentives.
• Employee assistance program.
• Life and disability insurance coverage.
• Generous paid time off including vacation, sick, personal days, and eight paid holidays.

Additional Information

Flourish Research is an equal opportunity employer, making employment decisions based on merit and business needs without regard to legally protected characteristics. The company complies with all regulations providing reasonable accommodation for employees with disabilities and handicaps.