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Senior Regulatory Associate, Surgery
- Dallas, Texas, United States
- Dallas, Texas, United States
Über
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
The Sr Regulatory Associate for the Department of Surgery's Surgical Partners in Research (SPAR) office supports the department's regulatory and compliance activities by conducting and providing oversight of coordinating, maintaining, and monitoring regulatory documentation and Institutional Review Board (IRB) submissions in accordance with applicable federal, state, institutional, and sponsor requirements. This role provides guidance and training for the department's regulatory associates, as well as collaborates closely with research sponsors, clinical research coordinators, and principal investigators to support regulatory processes across various studies such as medical device and drug studies. The ideal candidate demonstrates a strong interest and experience in clinical research and regulatory affairs, with particular enthusiasm for surgical, medical device, and pharmaceutical research. Prior clinical research coordination experience is highly valued.
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 coverage100% coverage for preventive healthcare-no copayPaid Time Off, available day oneRetirement Programs through the Teacher Retirement System of Texas (TRS)Paid Parental Leave BenefitWellness programsTuition ReimbursementPublic Service Loan Forgiveness (PSLF) Qualified Employer Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION
RequiredEducation
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 PreferredEducation
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 DUTIESCollaborates 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.
Sprachkenntnisse
- English
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