Regulatory Associate, Temporary at UT Southwestern Medical Center

Dallas, Texas, United States -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Project Management, Communication, Customer Service, Technical Assistance, Teamwork, Data Management, Ethical Principles, Scientific Research, Animal Care, Human Subject Protection, Multi-tasking, Medical Terminology, Quality Assurance, Training, Supervision

Industry

Higher Education

Description

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 Works under limited supervision to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies ethical principles and multiple regulations to complex scientific research projects. This is a full-time temporary assignment expected to last at least 3 months. The assignment will be primarily remote, with onsite presentation as needed to complete job duties. BENEFITS This position is not benefits eligible. EXPERIENCE AND EDUCATION Required Education Bachelor's Degree or equivalent Experience 2 years of related experience May consider experience and education in lieu of requirements. JOB DUTIES Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities. Various administrative and clerical assignments filled on an as needed basis. KNOWLEDGE, SKILLS, & ABILITIES Work requires effective oral and written communication skills Work requires project management and multi-tasking skills Work requires knowledge of regulations governing human subject protection and/or animal care and use Work requires strong customer service skills Work requires knowledge of medial terminology and ability to provide technical assistance and guidance Work requires computer proficiency for data management and electronic submissions Work requires ability to work in a team-oriented setting The following is the acronym, "PACT", and is fundamental to all non-clinical positions at UT Southwestern Medical Center: P-Problem Solving: Employees take ownership in solving problems effectively, efficiently, and to the satisfaction of customers, or managers. They show initiative in addressing areas of concern before they become problems. A-Ability, Attitude and Accountability: Employees exhibit ability to perform their job and conduct themselves in a professional and positive manner reflecting a professional environment readily assuming obligations in a dependable and reliable manner. C-Communication, Contribution, and Collaboration: Who are our Customers? Anyone who requests our help, needs our work product, or receives our services. Employees focus on customer service with creative solutions while improving the customer experience through clear, courteous, and timely delivery and communication. Sharing ideas with others helps expand our contribution to department goals. T-Teamwork: Employees work to contribute to the department’s success by supporting co-workers, promoting excellence in work product and customer service, and in maintaining a satisfying, caring environment for each other. WORKING CONDITIONS Work is performed primarily in office setting. 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.

Responsibilities

The Regulatory Associate will review study protocols and related documentation to ensure compliance with federal regulations. They will also provide supervision and guidance to lower-level Regulatory Assistants and consult with investigators on IRB/IACUC submissions.