Research Regulatory Affairs Specialist

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

📋 Description

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

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

• Prepare for auditing processes while adhering to stringent deadlines.

• Develop and maintain document management systems for regulatory electronic files.

• Ensure compliance with FDA and GCP regulatory documentation requirements for sites, studies, sponsors, and/or networks.

• Guarantee that regulatory documentation aligns with local Standard Operating Procedures for both format and content.

• Preserve essential documentation required for compliance.

• Revise and/or create informed consent forms.

• Update and manage modifications or amendments to protocols, investigator drug brochures, and consent forms in accordance with IRB policy and HIPAA regulations.

• Manage time-sensitive communications 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 substitute for educational requirements.

• A minimum of 1 year of experience in clinical research, pharmaceutical, or site management organizations with a focus on regulatory affairs is highly desirable.

• Familiarity with medical terminology is strongly preferred.

• Knowledge of FDA and other regulatory processes is highly preferred.

• Capability to manage a full workload of studies with minimal oversight.

• Understanding of IRB policy and HIPAA compliance is essential.

• Awareness of FDA and GCP regulatory documentation requirements is necessary.

• Ability to meet strict deadlines and prepare for auditing processes.

🏝️ Benefits

• Comprehensive Total Rewards package that supports physical, mental, and financial well-being.

• Competitive compensation package.

• Opportunities for annual bonuses or long-term incentives may be available.

• Equity options may be included in the compensation package.

• McKesson's benefits offerings.