Regulatory Compliance Specialist

🔥 1 minute ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Flourish Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Pharmaceuticals

Flourish Research is a national, multi-site clinical trial network and site operator that runs paid clinical studies across the United States. It provides end-to-end clinical research solutions — from first-in-human and early in-patient Phase I studies through Phase II–IV trials — and partners with pharmaceutical sponsors and CROs to accelerate trial execution using wholly-owned sites, experienced investigators, recruitment technology, and access to diverse and underrepresented patient populations. The company operates dozens of clinic locations across many U. S. states, specializes in therapeutic areas including cardiometabolic, oncology, neuroscience, infectious disease and vaccines, and emphasizes patient-centric care, high retention, and regulatory-quality study delivery.

📋 Description

• 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

• 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

• 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.