Senior Regulatory Analyst, HRPP

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.

ESSENTIAL FUNCTIONS 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.

QUALIFICATIONS Education and Experience Required

Education

Bachelor’s Degree in related field

Experience

5 years of related research experience with Bachelor’s degree. or

3 years of related research experience with Master’s degree.

Preferred

Education

Master’s Degree Advanced science degree strongly

Experience

Previous service on an Institutional Review Board or Institutional Animal Care and Use Committee (IACUC) a plus.

Licenses and Certifications

CPIA) CERT PROF IN IACUC ADMINISTRTN or CIP or extensive current knowledge of regulations governing human or animal research protections strongly 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

Working Conditions

Office Setting

PACT STATEMENT 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.

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 StatementUT 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.