Regulatory Specialist, Urology

UT Southwestern Medical Center • Dallas, TX

50d

About The Position

This position will provide full regulatory support to the Department of Urology which has approximately 36 faculty. This position will work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials. Perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issue that will affect the likelihood of IRB approvals.
The employee will be expected to perform the below job duties along with the duties listed in the "Job Duties" section:
· Prepares, submits, and revises all IRB or IACUC applications. Prepares and submits renewal and audit reports.
· Responsible for the review and initial start-up of budgets
· Monitors and evaluates research project quality control activities.
· Ensure all regulatory requirements are met and make recommendations as needed
· Provide training to employees on regulatory requirements and compliance procedures

Requirements

• Bachelor's Degree
• 7 years of job-related experience in development, review, oversight, or performance management of human clinical trials.

Nice To Haves

• Master's Degree in health sciences field.
• Previous service on an Institutional Review Board a plus.

Responsibilities

• Collaborates closely with the IRB and other regulatory entities at the institution to provide optimal protocol review services for investigators.
• Directs, analyzes, coordinates, and evaluates clinical trials program operation and procedures.
• Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from clinical trials program.
• Establishes clinical trials program goals and objectives and directs clinical trials program evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
• Recommends new policies and procedures for improvement of program activities.
• Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
• Ensures compliance with applicable laws, regulations, policies, and procedures.
• 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.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 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: Mid Level
• Number of Employees: 5,001-10,000 employees