Senior Regulatory Associate, Simmons Cancer Center

UT Southwestern Medical Center • Dallas, TX

11d • Onsite

About The Position

Join UT Southwestern as a Senior Regulatory Associate (RA) in Simmons Comprehensive Cancer Center Education and Training Office for cancer research. In this role, you will be primarily responsible for regulatory support of a specific Disease Oriented Team's (DOT) clinical trials under the leadership of the Cancer Center Associate Director of Clinical Research 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 trainings. This position will also mentor the entry level and mid-level staff on the team.

Requirements

• Bachelor's Degree
• 3 years of related experience in review, oversight, or performance management of scientific research projects.
• Experience and education may be considered in lieu of requirements.

Nice To Haves

• Advanced degree in a health sciences field
• Previous service on an IRB or IACUC
• Certified Professional

Responsibilities

• Provide regulatory support for clinical trials within a specific Disease Oriented Team (DOT).
• Review study protocols and draft consent forms.
• Complete IRB and/or FDA submissions, including initial submissions, modifications/amendments, continuing reviews, and study closures.
• Maintain essential regulatory documents, both electronic and paper.
• Prepare and facilitate DOT studies for long-term storage.
• Assist with and maintain CTEP IDs for physicians.
• Provide regulatory training for staff.
• Mentor entry-level and mid-level regulatory staff.
• Collaborate with the IRB, IACUC, and other regulatory entities for protocol review services.
• Prepare, submit, and revise IRB or IACUC applications, renewal, and audit reports.
• Maintain working relationships with internal/external departments and organizations associated with research projects.
• Monitor and evaluate research project quality control activities.
• Train personnel on IRB, IACUC, and HIPAA compliance, and information security protocols.
• Recommend new policies and procedures for program compliance.
• Ensure compliance with applicable laws, regulations, policies, and procedures.
• Responsible for the design, execution, and effectiveness of internal controls.
• Stay updated on scientific, regulatory, and technical developments related to clinical research oversight.
• Perform other duties as assigned.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior