Regulatory Specialist – Clinical Research

About Equity Medical

Equity Medical is a rapidly expanding clinical research organization dedicated to enhancing healthcare outcomes by increasing access to innovative clinical trials within the communities it serves.

Job Overview

We are searching for a detail-oriented, highly organized Regulatory Specialist to join our team at the Nashville, Tennessee location. This role requires comprehensive knowledge of regulatory activities at clinical research sites and the ability to manage multiple deadlines while ensuring documentation stays accurate and audit-ready.

Key Duties and Responsibilities

• Compile, review, and maintain essential regulatory documents for ongoing clinical research studies.
• Oversee management of regulatory binders and Investigator Site Files to guarantee completeness, up-to-date status, and readiness for audits.
• Coordinate submissions to Institutional Review Boards, sponsors, CROs, and other involved entities, maintaining tracking systems to monitor status.
• Support study initiation activities, including assembling regulatory documentation, preparing submissions, and enabling site activation.
• Monitor approvals, continuing reviews, amendments, safety reports, expiration dates, investigator credentials, licenses, CVs, and training records to ensure compliance.
• Conduct thorough reviews of regulatory documents for accuracy and completeness prior to submission.
• Maintain critical logs such as delegation logs, financial disclosures, Form FDA 1572s, protocol signature pages, and laboratory paperwork.
• Collaborate effectively with investigators, clinical research coordinators, site leadership, sponsors, CROs, and monitors.
• Prepare for and facilitate sponsor monitoring visits, audits, and regulatory inspections.
• Identify any missing or expiring documentation and follow up promptly to address these gaps.
• Keep regulatory and clinical trial information current in clinical trial management and electronic regulatory systems.
• Adhere strictly to company SOPs, ICH-GCP guidelines, FDA regulations, sponsor policies, and applicable federal and state regulations.
• Execute other regulatory and administrative tasks as assigned.

Qualifications and Experience

• Bachelor's degree preferred in life sciences, healthcare, clinical research, or a related discipline.
• A minimum of two years' experience in clinical research regulatory functions is strongly preferred.
• Background in clinical research sites, site networks, CROs, or academic medical centers is desirable.
• Familiarity with ICH-GCP standards, FDA regulatory requirements, essential clinical trial documents, and regulatory operations at the site level is necessary.
• Proven ability to support multiple concurrent clinical studies and meet competing deadlines.
• Exceptional organizational skills, keen attention to detail, and strong document management capabilities.
• Effective verbal and written communication skills.
• Proficient with Microsoft Office or Google Workspace tools.
• Experience with electronic regulatory management platforms such as CRIO, Florence eBinders, Veeva, or similar CTMS/eRegulatory software is preferred.

Position Requirements

• This is an on-site role based in Nashville, Tennessee; remote or hybrid work options are not available.
• Candidates must be able to work in person during standard business hours.
• Employment is contingent upon successful completion of required pre-employment processes.

Why Work with Equity Medical?

• Opportunity to be part of a swiftly growing clinical research organization.
• Contribute to impactful work aimed at advancing new therapies for patients.
• Collaborate with seasoned clinical research professionals in a supportive environment.
• Grow professionally in a culture that prioritizes quality, responsibility, and career development.

Equal Opportunity Statement

Equity Medical, LLC is committed to equal employment opportunities for all qualified candidates.