Summary

The Regulatory Affairs Associate works to provide centralized support within the Office of Clinical Research (OCR) to multiple Principal Investigators (PIs) across the College and its affiliates. Supports all aspects of regulatory compliance, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees, and ensuring successful navigation of approval processes for both therapeutic drug and device trials in varying disease areas with multiple departments. The role requires expertise and understanding of multiple therapeutic indications and applicable regulations. The Regulatory Affairs Associate is expected to interface with other academic centers, NIH funded consortia, the Federal Drug Administration (FDA), and industry sponsors on highly sensitive and confidential projects. This is an onsite role, located at McNair Campus and will work alongside the Principle Investigators and research team. The ideal candidate will be self-motivated, organized and detail oriented. Travel to campus locations in the Texas Medical Center is expected. This is a full-time position, generally working within normal business hours of Monday-Friday, 8am-5pm.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

• Coordinates efforts associated with the preparation of regulatory start-up and ongoing clinical trials documents.
• Communicates with Central and local IRBs, CROs, Sponsors and PIs related to new protocols and protocol amendments, are submitted appropriately and continuing reviews are submitted in a timely manner Supports PI's and study staff by assisting in the data collection and notification required for reporting of Adverse Events Compiles and maintains regulatory documentation electronically and investigator site file.
• Coordinates, prepares, or reviews regulatory submissions for Central IRBs, BCM IRB and affiliates.
• Works closely with study team, research staff and PI's to ensure that all regulatory documents for research studies are up-to-date so as to streamline work and achieve mutual goals.
• Keeps the research study team and Manager informed of protocol related issues.
• Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• Coordinates and submit timely responses to CRO's, Sponsors, Central and BCM IRB, PI's inquiries.
• Reports and responds to agencies inquiries or comments.
• Assists with and prepares for FDA meetings, inspections, and audits from regulatory agencies.
• Prepares regulatory reports and coordinate data collection and reporting with other departments.
• Maintains study regulatory database, OCR regulatory database as applicable.
• Assists with regulatory affairs training.
• Assists Investigators with assurance with ClinicalTrials.gov and funding entity requirements.
• Provides coverage for team members as needed.
• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Preferred Qualifications

• Organized, self-motivated, teamwork, works well under pressure, multitasking