Senior Regulatory Analyst, HRPP

JOB SUMMARY
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.

Job Duties

• 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.

Required

Preferred

Knowledge, Skills and Abilities

• Work requires excellent verbal, written, and interpersonal communication skills to work effectively with all levels of staff, faculty, and scientists.
• Work requires ability to read, write, analyze data, develop plans and procedures, and coordinate resources to accomplish goals.
• Work requires ability to provide technical assistance and consultation to physicians and other scientists.
• Work requires responsibility for review, recommendation, development, and implementation of policies.
• Work requires computer proficiency and comfort with electronic technology for data management.

PHYSICAL DEMANDS/WORKING CONDITIONS

PACT STATEMENT

Salary
Salary Negotiable

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 Statement

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.