Regulatory Affairs Associate

Senior Regulatory Associate - Simmons Cancer Center WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY 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. BENEFITS UT 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 EDUCATION Required 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. SECURITY AND EEO STATEMENT Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. EEO UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. #J-18808-Ljbffr