Regulatory Compliance Specialist I

About Us

Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence in clinical trials and healthcare, ensuring everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all are included and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives and ideas we share, and the better prepared we are to serve our communities.

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives!

About the Role

We are actively hiring a remote Regulatory Compliance Specialist I. This is a non-exempt position with a Monday-Friday day shift (40 hours per week) and a compensation range of $24.00-$28.00 per hour.

Responsibilities

• 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 Research 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
• Assist with developing and implementing key initiatives in the department
• Assist with identifying and implementing process improvements
• Seek out opportunities to help achieve department/company goals
• Foster relationships across teams
• Consistently accomplish 80% of individual quarterly goals and objectives
• Assist with training and mentoring department new hires
• Demonstrate good critical thinking and decision-making skills resulting in sound judgment
• Additional duties as assigned by management

Requirements

Physical Requirements and Environmental Factors

• Work is performed in a typical interior office setting
• Local travel required
• Daily computer use
• Occasional evening and weekend work schedules
• Ability to properly lift up to twenty-five pounds and occasionally more than twenty-five pounds
• Ability to drive and daily availability of an automobile

Minimum Requirements

• Bachelor's degree or equivalent experience
• Minimum of 3 years' experience within the field of clinical or biological research

Skills

• Exceptional knowledge of clinical research methods
• Consistently demonstrates core values & proficiency of skills set
• Experienced with Microsoft Office applications (Outlook, Word, and Excel) as well as internet-based applications
• Detail-oriented, organized, self-motivated, and able to work independently and on a team
• Excellent interpersonal skills including written and verbal communications
• Moral and ethical in decision-making and during interactions with patients, sponsors, IRB representatives, physicians, and staff
• Professionalism and a strong work ethic
• Ability to adapt and take on additional tasks as requested
• Ability to solve problems while working closely across departments
• 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
• Industry certified as applicable

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, personal days, and 8 paid holidays