Regional Regulatory Specialist

Flourish Research•Matthews, NC

23h•$24 - $29•Onsite

About The Position

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.

Requirements

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

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