JOB SUMMARYThe purpose of this job is to work closely with investigators and research personnel on the refinement of protocol and other documents for the performance of research projects. Perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB or IACUC approvals.
The Regulatory Associate Senior will be primarily responsible for regulatory support of a specific Disease Oriented Team's (DOT) clinical trials as well as provide support and backup for other DOTs as needed. The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long term storage at Iron Mountain. In addition, each regulatory team member provides ancillary services such as assisting with and maintaining the CTEP IDs for physicians as well as staff regulatory training. This position will also mentor the entry level and mid-level staff on the team as well as cover the regulatory support for the fast track program.
Regulatory experience in Clinical Research strongly preferred.
BENEFITSUT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
- PPO medical plan, available day one at no cost for full-time employee-only coverage
- 100% coverage for preventive healthcare-no copay
- Paid Time Off, available day one
- Retirement Programs through the Teacher Retirement System of Texas (TRS)
- Paid Parental Leave Benefit
- Wellness programs
- Tuition Reimbursement
- Public Service Loan Forgiveness (PSLF) Qualified Employer
- Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATIONRequired- Education
Bachelor's Degree
- Experience
3 years of related experience in review, oversight, or performance management of scientific research projects.
May consider experience and education in lieu of requirements
Preferred- Education
Advanced degree in health sciences field
- Experience
Previous service on an IRB or IACUC a plus.
- Licenses and Certifications
CERTIFIED PROFESSIONAL or
Previous service on an IRB
JOB DUTIES- Collaborates closely with the IRB, IACUC, and other regulatory entities at the institution to provide optimal protocol review services for investigators.
- Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
- Maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from associated research projects.
- Monitors and evaluates research project quality control activities. Trains personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
- Recommends new policies and procedures for improvement of program compliance activities. Ensures compliance with applicable laws, regulations, policies, and procedures.
- Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
- Reads literature and attends training and other functions as necessary to keep abreast of relevant scientific, regulatory, and technical developments related to oversight of clinical research.
- Performs other duties as assigned.
