Senior Regulatory Analyst, Human Research Protection IRB

UT Southwestern Medical Center•Dallas, TX

About The Position

The Senior Regulatory Analyst works closely with investigators and research personnel to develop and refine proposals for human clinical trials or animal research. For campus-wide research, the role conducts thorough protocol pre-review before submission to the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC), and provides technical consultation to Principal Investigators on regulatory, scientific, and policy issues that may affect approval. The position applies expert knowledge of regulations and institutional policies, reviews complex research documents, supports committee operations and decisions, and helps improve protections for research subjects.

Requirements

Bachelor's degree in a related field.
Five years of related research experience with a bachelor's degree, or three years of related research experience with a master's degree.
Expert-level knowledge of applicable federal regulations, state regulations and policies, and institutional policies relevant to human or animal research and privacy.

Nice To Haves

Master's degree; an advanced science degree is strongly preferred.
Previous service on an Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC).
Certification as a Certified Professional in IACUC Administration (CPIA) or Certified IRB Professional (CIP), or extensive current knowledge of regulations governing human or animal research protections.

Responsibilities

Provide expert-level knowledge and interpretation of federal and state regulations and institutional policies relevant to human or animal research and privacy.
Review complex scientific research documents and identify substantive ethical, regulatory, and institutional policy issues.
Approve protocol submissions eligible for expedited or designated-member review.
Document decision-making in reviewer checklists, databases, and correspondence as required by federal regulations.
Guide research committee staff, board members, chairs, and researchers in resolving complex and controversial issues.
Recommend and implement solutions to customer and inter-institutional processes related to protocol submissions and regulatory review.
Direct, analyze, coordinate, and evaluate research committee operations and procedures.
Document controverted ethical and scientific issues in meeting minutes and summarize judgments and resolutions for each review item.
Keep current on regulatory changes through literature review, training, and other activities, and consider implications for institutional review processes.
Provide education and training to faculty, study staff, HRPP/IACUC Office staff, and board members; develop and distribute resource materials to improve research-subject protections.
Prepare, send, and track incident notifications to researchers, institutional leadership, and federal officials as required by regulations.
Respond to follow-up inquiries from federal agencies, faculty, and affiliated-institution officials regarding research committee notifications.
Develop and maintain working relationships with internal and external departments, agencies, and organizations associated with or benefiting from the research program.
Establish research committee goals and objectives; direct committee evaluation and quality-control activities; and develop or approve schedules, priorities, and standards.
Design, execute, and maintain effective internal controls that provide reasonable assurance of effective and efficient operations.
Perform other duties as assigned.

Benefits

PPO medical plan, available on the first day at no cost for full-time employee-only coverage.
100% coverage for preventive healthcare with no copay.
Paid time off, available on the first day.
Retirement programs through the Teacher Retirement System of Texas (TRS).
Paid parental leave.
Wellness programs.
Tuition reimbursement.
Public Service Loan Forgiveness (PSLF) qualified employer.
On-site childcare.
Merit increases.