[Hiring] Regional Regulatory Manager @Flourish Research

Role Description

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.

Qualifications

• High School Diploma. College degree preferred, however not required.
• 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).

Requirements

• Exceptional knowledge of clinical research methods.
• Strong management and leadership skills.
• Consistently demonstrates core values and high proficiency of skills set.
• Demonstrated ability to collaborate and align with operations.
• Excellent interpersonal skills including written and oral communications.
• Moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics and other employees.
• Strong work ethic, motivated to identify tasks that need to be completed and to strive for accuracy and quality when completing assignments.
• 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.
• A generous PTO plan covering vacation, sick, personal days and 8 paid holidays.