Regulatory Compliance Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Prepare, oversee, and maintain all regulatory documents related to research.

• Coordinate and manage the complete process of submitting initial regulatory documents to the IRB, sponsors, and relevant state or federal regulatory agencies as required.

• Compile study details and submit initial, ongoing, and final reports to the IRB and/or sponsor.

• Prepare relevant submission forms and ensure updated documents are submitted, including but not limited to: Amendments, Addendums, Investigator’s Brochures, Safety Information, Form FDA 1572s, and informed consent documents.

• Accurately file and keep all necessary logs in the regulatory binder(s).

• Assist in managing the archiving of clinical trial documents and records.

• Prepare for monitoring visits and audits.

• Manage and update the Curricula Vitae of full-time and contract employees, ensuring all current medical/nursing licenses, certifications, and other required regulatory documents are on file.

• Comply with all HIPAA regulations.

• Maintain the confidentiality of sponsor and Flourish trade secrets.

• Produce error-free written documents and reports (e.g., cover letters, notes-to-file, memos, etc.).

• Seek additional assignments upon completion of other tasks.

• Execute all responsibilities in a timely and cost-effective manner.

• Represent Flourish Research professionally and courteously (in verbal, written communication, and appearance) when interacting with all staff, clients, and vendors.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

• At least 3 years of experience in clinical or biological research.

• Strong knowledge of clinical research methodologies.

• Proficiency in Microsoft Office applications (Outlook, Word, and Excel) as well as internet-based applications.

• Detail-oriented, organized, self-motivated, capable of working independently and as part of a team, with the ability to maintain focus on tasks.

• Excellent interpersonal skills, including strong written and verbal communication.

• Ethical and moral in decision-making and interactions with patients, sponsors, IRB representatives, physicians, staff at satellite clinics, and other employees.

• Ability to adapt and take on additional tasks as needed.

• Problem-solving skills while collaborating closely across departments.

• Contribute to the development and implementation of key initiatives in the department.

• Assist in identifying and executing process improvements.

• Seek opportunities to help achieve departmental and company objectives.

• Build relationships across teams.

• Consistently achieve 80% of personal quarterly goals and objectives.

• Assist in training and mentoring new hires in the department.

• Exhibit strong critical thinking and decision-making skills leading to sound judgment.

• Industry certification as applicable.

• Proven ability to collaborate and align with operations.

• Flexible, capable of multitasking, and prioritizing competing demands.

• Ability to think independently and exert influence when appropriate.

🏝️ Benefits

• 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, and personal days, along with 8 paid holidays.