Regional Regulatory Manager

About Us:

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. 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.

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.

WESEEYOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!

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! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

We are actively hiring a Regional Regulatory Manager. This is a remote position.

Shift: Monday-Friday (40 hours per week)

Location:

Remote
- United States

PURPOSE:

To oversee, manage and coordinate regulatory documents and activities throughout all clinical research studies conducted by the regional Flourish Research sites according to Flourish Research’s SOPs, policies and procedures, applicable federal regulations, medical ethics, International Council of Harmonization (ICH), Good Clinical Practices (GCPs), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. To work closely with site leadership, principal investigators, and site staff.

To collaborate with Sponsors, CROs, and IRB staff.

Role functions begin at the time of study start-up, continuing through the duration of the trial, and until after study is deemed closed. All responsibilities should be completed in accordance with Flourish Research’s Core Values and Employee Manual.

• A. Provide guidance and support to ensure the team meets all regulatory requirements and deadlines.
• B. Manage and oversee full-time and contract employee Curricula Vitae and ensure copies of all current and applicable licenses and certifications are on file.
• C. Regulatory lead for audits and inspections.
• D. Follow and ensure compliance with Flourish SOPs by team members.
• E. Manage the tactical and regulatory execution of awarded clinical research trials by overseeing timelines and staff for regulatory start up.
• F. Oversee the preparation, submission, and maintenance of regulatory documents, including IRB submissions, amendments, and renewals.
• G. Provide guidance on administrative and regulatory aspects for all areas within the assigned region.
• H. Establish and maintain effective channels of communication and dissemination of vital communication with the regulatory team, site management/delegate, and RDO.
• I. Collaborate with management to develop staff, structure department, and create a highly desirable work environment for attracting and retaining highly qualified professionals.
• J. Develop and implement strategies through collaboration with the site and regulatory teams to identify and develop efficient systems and tools that enhance department efficiency, streamline regulatory processes, and improve overall efficiency, while maintaining quality.
• K. Maintain a high…