Regulatory Specialist

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 Regulatory Specialist at the Flourish Research site in Winter Park FL!

The Regulatory Specialist is responsible for managing and coordinating regulatory documents and activities for clinical research studies conducted at Flourish Research. This role involves working with site leadership principal investigators and regulatory bodies to ensure compliance with Flourish Researchs standards federal regulations and sponsor protocols.

Shift: Monday - Friday 8 AM - 5 PM
Location:1788 W Fairbanks Ave Suite A Winter Park FL 32789
Compensation: Competitive hourly rate based on experience
Benefits: Health dental and vision insurance plans 401(k) with 4% match tuition reimbursement parental leave referral program employee assistance program life insurance disability insurance and 15 days of PTO 10 company holidays.

RESPONSIBILITIES

• Prepare maintain and oversee all research-related regulatory documents
• Manage the full lifecycle of regulatory submissions to IRBs sponsors and regulatory agencies
• Submit study updates including amendments safety info FDA 1572s and consent forms
• Maintain accurate logs and ensure proper regulatory filing and archival of documents
• Prepare for monitoring visits and audits
• Distribute collect and track essential site regulatory documents (CVs licenses training certs etc.)
• Maintain both paper and electronic regulatory files for all active studies
• Ensure confidentiality of study protocols and Protected Health Information (PHI)
• Draft clear error-free written communications and documentation
• Execute duties safely efficiently and in alignment with company policies
• Represent Flourish Research professionally in all internal and external interactions
• Perform additional duties as assigned by management

QUALIFICATIONS

• High school diploma or equivalent required; college degree preferred
• 03 years of experience in clinical or biological research
• Proficient in Microsoft Office (Outlook Word Excel) and platforms such as CTMS eRegs/eDocs
• Highly detail-oriented organized and self-motivated
• Able to work independently and collaboratively in a fast-paced environment
• Strong written and verbal communication skills
• Ethical and professional in interactions with patients sponsors IRBs and staff
• Strong critical thinking and problem-solving abilities
• Demonstrates a high level of professionalism and work ethic
• Flexible and willing to take on additional tasks as needed
• Effective at cross-departmental collaboration and issue resolution
• Contributes to departmental initiatives and process improvements
• Assists in training new team members
• Meets or exceeds 80% of annual goals
• Excellent computer skills including proficiency with Office365

Flourish Research offers an excellent comprehensive benefits package a supportive and collaborative work environment and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!

Flourish Research is where clinical trials thrive.

Flourish Research represents one of the industrys most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal CNS pulmonology and vaccines.

At Flourish Research we strive toward 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 Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees customers and patients are included and treated with dignity and respect.

Flourish Research strives to build an organization that attracts and leverages diversity in our staff which reflects the diversity of our local communities. We promote education acceptance and inclusion because there is beauty in diversity. 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!

It is the policy of Flourish Research not to discriminate against any applicant for employment or any employee because of age color sex disability national origin race religion or veteran status.