Flourish Research

Regulatory Compliance Specialist

United States · Full-time

Sponsorship not specified$24k-$28kDetected 7 days ago

ComplianceExcelCustomer SupportHIPAAClinical TrialsClinical ResearchFDA RegulatoryResearchCritical ThinkingMentoringMicrosoft Office

About the role

In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status.
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!
Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor.

Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.).
Accurately file and maintain all necessary logs within the regulatory binder(s).
Assist in and manage the archival of clinical trial documents/records.
Maintain confidentiality of sponsor and CTT trade secrets.
Populate and coordinate the entire process of initial regulatory documents' submission to the IRB, sponsors and state or federal regulatory offices as necessary.
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.
Perform all duties in a time- and cost-effective manner.
Ability to drive and daily availability of an automobile.

Knowledge and Skills: Exceptional knowledge of clinical research methods.
Must be detail oriented, organized, self-motivated, be able to work independently and one team, and the ability to stay on task.

Bachelor's degree or equivalent experience Minimum of 2+ years at CTT plus 103 years' experience within the field of clinical or biological research.

Exceptional knowledge of clinical research methods.
Consistently demonstrates core values & proficiency of skills set.
Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications.
Demonstrates excellent interpersonal skills including written and verbal communications.
Demonstrates professionalism, and a strong work ethic.
Must have the ability to adapt and take on additional tasks as requested.
Ability to solve problems while working closely across departments.
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.

$24.00-$28.00 per hour Prepare, maintain and provide oversight to all research-related regulatory documents.

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.

Flourish Research is where clinical trials thrive.
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.
We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish is committed to a safe work environment where all employees, customers, and patients 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.
WE EMBRACE YOU.
WE CELEBRATE YOU!
We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
About the Job: We are actively hiring a Regulatory Compliance Specialist.
Shift: Monday-Friday day shift (40 hours per week) Location: Remote FLSA Classification: Non-Exempt
We are actively hiring a Regulatory Compliance Specialist.

Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor.
Monitor/Sponsor/IRB Customer Service Daily computer use.

This listing is sourced directly from Flourish Research's careers page and normalized into a canonical job model.