This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Oversee and strategize compliance with regulatory affairs for industry sponsors and/or sites within networks.

• Collaborate closely with regulatory affairs management, department directors, and/or primary investigators to ensure adherence to compliance standards.

• Prepare thoroughly for auditing activities while adhering to strict timelines.

• Manage a full study workload independently with minimal supervision.

• Create and sustain a document management system for regulatory electronic files.

• Ensure maintenance of FDA- and GCP-required regulatory documentation for individual sites, studies, sponsors, and/or other networks.

• Verify that regulatory documentation meets local Standard Operating Procedures (SOPs) in terms of format and content.

• Maintain essential documentation to ensure compliance.

• Alter and/or create informed consent forms and manage protocol, investigator drug brochure, and consent form modifications or amendments in accordance with IRB policy and HIPAA regulations.

• Handle time-sensitive communication with sponsors and other stakeholders.

• Organize and process documentation for IRB submissions across multiple trials.

• Address protocol deviations that meet IRB reportable criteria.

• Submit urgent safety notifications to the IRB.

• Perform additional duties as assigned.

⛳️ Requirements

• A high school diploma is required.

• An Associate's Degree or higher is preferred.

• Relevant experience may be accepted in lieu of educational qualifications.

• A minimum of 3 years' experience in regulatory affairs within a clinical research, pharmaceutical, or site management organization is highly desired.

• Familiarity with medical terminology, FDA regulations, and other regulatory processes is strongly preferred.

• A work location based in the US is required.

• Work sponsorship is not available.