Regulatory Compliance Specialist I

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

📋 Description

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

• Coordinate and populate initial regulatory submissions to the IRB, sponsors, and relevant state or federal regulatory bodies as required.

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

• Create submission forms and submit updated documents, including amendments, addendums, Investigator’s Brochures, safety information, Form FDA 1572s, and informed consent documents.

• Diligently file and maintain essential logs within regulatory binders.

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

• Prepare for monitoring visits and audits.

• Oversee and update full-time and contract employees' curricula vitae, ensuring current medical/nursing licenses, certifications, and other required regulatory documents are maintained.

• Comply with HIPAA regulations.

• Preserve the confidentiality of sponsor and Flourish Research trade secrets.

• Produce accurate written documents and reports, including cover letters, notes-to-file, and memos.

• Pursue additional assignments upon completion of other tasks.

• Execute responsibilities in a time-efficient and cost-effective manner.

• Represent Flourish Research with professionalism and courtesy when engaging with staff, clients, and vendors.

• Perform other tasks as assigned by management.

⛳️ Requirements

• Bachelor’s degree or equivalent experience.

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

• Work performed in a standard interior office environment.

• Local travel required.

• Experience in Monitor/Sponsor/IRB Customer Service.

• Daily computer usage.

• Occasional evening and weekend work commitments.

• Ability to lift up to twenty-five pounds and occasionally more than that.

• Must have a valid driver's license and daily access to a vehicle.

• Extensive knowledge of clinical research methodologies.

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

• Detail-oriented, organized, self-driven, capable of working independently and collaboratively, and able to remain focused on tasks.

• Excellent written and oral communication skills.

• Strong moral and ethical decision-making capabilities.

• High level of professionalism and a strong work ethic.

• Ability to adapt and take on additional responsibilities.

• Problem-solving skills with a collaborative approach across departments.

• Capable of assisting in the development and execution of departmental initiatives.

• Ability to identify and implement process improvements.

• Competence in helping to achieve department and company objectives.

• Ability to build relationships across teams.

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

• Ability to assist in training and mentoring new hires in the department.

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

• Industry certification as applicable.

• Proven ability to collaborate and align with operational teams.

• Flexible, able to multitask, and prioritize competing demands.

• Capacity to think independently and exert influence when necessary.

🏝️ Benefits

• Health, dental, and vision insurance plans.

• 401(k) plan 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.

• Comprehensive PTO plan covering vacation, sick, personal days, and 8 paid holidays.