Regional Regulatory Specialist at Flourish Research

Matthews, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

29.0

Posted On

28 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Document Management, Clinical Research Studies, Compliance, IRB Submissions, Sponsor Protocols, Regulatory Agencies, Safety Information, Regulatory Filing, Audits, Electronic Regulatory Files, Confidentiality, Written Communication, Critical Thinking, Problem-Solving, Cross-departmental Collaboration, Process Improvements

Industry

Biotechnology Research

Description

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 Specialist at the Flourish Research site in Charlotte! 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 Research's standards, federal regulations, and sponsor protocols. Shift: Monday - Thursday, 7:30 AM - 5 PM, occasional Fridays from 8 AM - 12 PM Location: 10801 Monroe Rd, Suite # 100, Matthews, NC 28105 Compensation: $24-$29/hr based on experience Benefits: Health, dental, and vision insurance plans, 401k 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 0–3+ 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 industry's 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 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 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! Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.

Responsibilities

The Regulatory Specialist is responsible for managing and coordinating regulatory documents and activities for clinical research studies, ensuring compliance with site standards, federal regulations, and sponsor protocols. This includes preparing, maintaining, and overseeing all research-related regulatory documents and managing submissions to IRBs, sponsors, and regulatory agencies.