Regulatory Affairs Associate - Full Time - Germantown, TN

West Cancer Center•Germantown, TN

13d

About The Position

The Regulatory Affairs Associate I works closely with sponsors, CROs, investigators, and research staff to coordinate regulatory submissions and approvals for multiple studies. The role manages Institutional Review Board (IRB) submissions, maintains regulatory documentation, processes safety reports, and ensures compliance with federal regulations while supporting ongoing research activities. The position also supports monitoring visits and audits, contributes to quality control and reporting, and assists with training and orientation of new employees.

Requirements

Two years of regulatory affairs or research experience.
Strong organization and follow-up skills.
Excellent verbal and written communication skills.
Familiarity with the Code of Federal Regulations and Good Clinical Practice (GCP).
Strong problem-solving skills.
Ability to organize and prioritize work assignments.
Ability to manage multiple priorities in a fast-paced environment.
Ability to analyze situations and respond in a timely manner.
Ability to work in multifunctional teams.
Proficiency in computer applications including Word, Excel, Adobe Acrobat, email, and internet research.

Nice To Haves

Associate’s or Bachelor’s degree.
Research certification.

Responsibilities

Coordinate initial and ongoing IRB approvals for assigned studies.
Maintain regulatory responsibility for multiple studies.
Collect and maintain site-specific regulatory documents, including CVs, licenses, lab certifications, FDA Form 1572, and delegation logs.
Prepare and submit study documents to the IRB, sponsors, and/or FDA as appropriate.
Maintain study binders with required documents and correspondence.
Meet study deadlines and coordinate with staff to obtain subject information needed for updates and re-approvals.
Perform study closeout activities as appropriate.
Maintain essential regulatory documents.
Obtain IRB approval for updated study documents, including protocol amendments, informed consent forms, Investigator Brochures, and patient materials.
Manage site changes, including regulatory updates and documentation.
Process safety reports.
Maintain working knowledge of federal regulations.
Participate in sponsor/CRO monitoring visits and audits.
Assist with report compilation, quality control of regulatory documents, and other assigned tasks.
Maintain professionalism and confidentiality in all interactions.
Assist with training and orientation of new employees.
Interface with external partners, including sites, sponsors, CROs, IRBs, and FDA.
Perform all other duties as assigned.