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. WE SEE YOU. 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.

About the Job:

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.

ESSENTIAL JOB FUNCTIONS:

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 level of professional expertise in the field and serve as SME for region.

L. Manage activities performed by assigned team to improve organizational performance.

M. Lead, mentor, manage, and train team members to foster growth and success of site(s) and team members.

N. Assist with screening/interviewing/hiring team members.

O. Conduct annual performance reviews according to Flourish policies and procedures and foster a culture of continuous improvement.

P. Contribute to process improvement initiatives by identifying trends and areas for improvement.

Q. When necessary, perform verbal and written disciplinary procedures according to Flourish policies and procedures.

R. Manage requests for time off by team members as well as their daily/weekly schedules to ensure adequate staffing at all times to meet the demands and department workload.

S. Abide by all HIPAA regulations.

T. Maintain confidentiality of sponsor trade secrets.

U. Create error free written documents and reports.

V. Perform all duties in a time- and cost-effective manner.

W. Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.

X. Additional duties as assigned by management.

PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:

A. Work is performed in an interior office work environment.

B. Travel may be required up to 50%.

C. Daily computer use.

D. Participant care.

E. Monitor/Sponsor customer service.

F. Occasional evening and weekend work schedules.

G. Ability to properly lift thirty-five pounds and occasionally more than thirty-five pounds.

H. Ability to drive and daily availability of an automobile.

Requirements

• MINIMUM REQUIREMENTS: Education: High School Diploma. College degree preferred. However, not required.
• Experience: Minimum of 5+ years’ experience in clinical or biological research. (Minimum of 3 years in the department plus 2 years in related role within clinical research industry.)
• Knowledge and Skills: A. Exceptional knowledge of clinical research methods.
• B. Strong management and leadership skills.
• C. Consistently demonstrates core values and high proficiency of skills set.
• D. Demonstrated ability to collaborate and align with operations.
• E. Must possess excellent interpersonal skills including written and oral communications.
• F. 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.
• G. Must have a strong work ethic, be motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments.
• H. Develops and implements key initiatives in the department.
• I. Identifies and implements process improvements for increased efficiencies.
• J. Builds and fosters relationships across teams.
• K. Serves as preceptor, mentor and subject matter export in department.
• L. Demonstrates strong critical thinking and decision-making skills resulting in sound judgement.
• M. Excellent computer skills to include Office365 products.
• N. Strong problem solving, risk assessment and impact analysis abilities.
• O. Demonstrated experience in process improvement.
• P. Flexible and able to multi-task and prioritize competing demands.
• Q. Ability to think independently and influence when appropriate