Bachelor's Degree in a related field required; Master's Degree preferred.
5 years of related research experience with a Bachelor's or 3 years with a Master's.
Experience on an Institutional Review Board or IACUC is a plus.
CPIA certification or extensive knowledge of human/animal research regulations preferred.
Strong analytical and communication skills essential.
Responsibilities
Provide expert knowledge of federal and state regulations related to human and animal research.
Review complex scientific documents for ethical and regulatory compliance.
Approve protocol submissions for expedited review when eligible.
Document decision-making processes in compliance with federal regulations.
Guide research committee staff and researchers on complex issues.
Implement solutions for protocol submission processes and regulatory reviews.
Educate faculty and staff on the protocol review process and improve protections for research subjects.
Benefits
PPO medical plan available at no cost for full-time employee-only coverage from day one.
100% coverage for preventive healthcare with no copay.
Paid Time Off available from day one.
Retirement Programs through the Teacher Retirement System of Texas.
Paid Parental Leave Benefit.
Wellness programs offered.
Tuition Reimbursement available.
Public Service Loan Forgiveness (PSLF) Qualified Employer.
Full Job Description
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.
BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:
PPO medical plan, available day one at no cost for full-time employee-only coverage
100% 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
Learn more about these and other UTSW employee benefits!
EXPERIENCE AND EDUCATION
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.
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.
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.
About University Of Texas Southwestern Medical Center
The University of Texas Southwestern Medical Center (UT Southwestern) is a public academic health science center in Dallas, Texas. With approximately 14,400 employees and an operating budget of nearly $2.8 billion, UT Southwestern is one of six medical schools in the UT System. UT Southwestern is one of the leading medical research institutions in the world, with a focus on biomedical research, clinical care, and education. The institution is home to six Nobel laureates, 22 members of the National Academy of Sciences, and 19 members of the National Academy of Medicine. UT Southwestern is also affiliated with Parkland Memorial Hospital, one of the largest public hospitals in the United States.
