Senior Regulatory Analyst, Human Research Protection

UT Southwestern Medical Center • Dallas, TX

13d • Onsite

About The Position

The purpose of this job is to work closely with investigators and research personnel on the development and refinement of proposals for the performance of human clinical trials or animal research. For campus-wide research, perform thorough protocol pre-review in advance of submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) and provide technical consultation to Principal Investigators on any regulatory, scientific, or policy issues that will affect the likelihood of IRB/IACUC approvals.

Requirements

• Bachelor's Degree in related field
• 5 years of related research experience with Bachelor's degree.
• 3 years of related research experience with Master's degree.

Nice To Haves

• Master's Degree Advanced science degree strongly
• Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC) a plus.
• (CPIA) CERT PROF IN IACUC ADMINISTRTN or CIP or extensive current knowledge of regulations governing human or animal research protections strongly preferred.

Responsibilities

• For campus-wide research, provide expert-level knowledge (application and interpretation) of federal regulations (DHHS, PHS, FDA, USDA, HIPAA, etc.), state regulations and policies, and institutional policies relevant to human or animal research and privacy. These include research related policies of UTSW.
• Review complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues.
• May approve protocol submissions eligible for expedited/designated member review.
• Document the decision making process as required by federal regulations in applicable reviewer checklists, database and correspondence
• Provide guidance to research committee staff, board members/chairs and researchers on resolving complex and controversial issues
• Solve, recommend and implements solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the regulatory review process
• Directs, analyzes, coordinates, and evaluates research committee operation and procedures. Capture and document in the minutes controverted ethical and scientific issues identified during the review process. Summarize judgments/resolution of issues for each item of review
• Reads literature and attends training and other functions as necessary to keep current on changes to regulations and consider implications for institutional review processes
• Provide education and training to faculty and study staff, HRPP/IACUC Office staff and Board members related to the protocol review process and develop and distribute resource materials in an effort to improve protections for research subjects
• Responsible for preparing, sending and tracking incident notifications to researchers, institutional leadership and federal officials as required by federal regulations (i.e., FDA, USDA, HHS, PHS, DOD, DOE, etc.).
• Respond to follow-up inquires by federal agencies, faculty, and officials from affiliated institutions regarding notifications from the research committee.
• Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
• Establishes research committee goals and objectives and directs research committee evaluation and quality control activities; develops and/or approves schedules, priorities, and standards for achieving goals.
• Responsible for design, execution, and effectiveness of system of internal controls, which provide reasonable assurance that operations are effective and efficient.
• 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: Senior