Clinical Research Regulatory Specialist – Hybrid in Nashville TN

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- Clinical Trials 200

The Research Regulatory Analyst will act as a liaison to the IRB and assist with coordinating the approval processes and regulatory components of research protocols from study start‑up to close‑out, such that the integrity and quality of the clinical/translational research is maintained, and the research is conducted in accordance with all regulatory policies.

Experience coordinating clinical research trials

Experience obtaining informed consent from study participants

Proficiency in Microsoft Excel and other Microsoft Office applications

Experience with REDCap data management systems

Clinical or translational research experience

Hands‑on involvement in all phases of clinical research trials IRB submission and regulatory compliance experience

Strong ability to manage multiple priorities in a fast‑paced environment

Exceptional attention to detail and organizational skills

Oncology research experience

Independently collects, reviews, organizes, assembles, and maintains regulatory documents/binders (paper and electronic) for assigned clinical trials, assuring the research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.

Independently prepares, reviews, and processes new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and federal regulations while maintaining timelines for studies from start‑up to close‑out.

Proficient with OnCore, Veeva, and project management tools.

With occasional guidance, initiates and performs quality control (QC) audits of regulatory documents from OnCore and Veeva.

Generates QC Report summarizing the findings.

Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges as evident by monitor/auditor follow‑up letters.

Assist with building relationships with internal/external stakeholders (i.e., monitors, auditors, and sponsors) by fostering a culture of respect and practicing active communication.

Demonstrates knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations.

Supports team working relationships within assigned departments between all levels of personnel by fostering a culture of respect, communication, and ownership.

The responsibilities listed are a general overview of the position, and additional duties may be assigned.

Communication (Intermediate):
Clearly, effectively, and respectfully communicate with employees or customers, including external and internal stakeholders i.e., monitors, auditors, and sponsors.

Problem Solving (Intermediate):
Uses critical thinking and process improvement i.e., coaches and mentors’ development of problem statement, describes current state, identifies root causes, creates future state, coaches and mentors’ development of solutions…