Senior Regulatory Analyst, Human Research Protection IRB

223002 - Human Research Protection IRB; Dallas (TX); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

UT Southwestern is seeking a Senior Regulatory Analyst for the Human Research Protection IRB to collaborate with investigators on proposals for human clinical trials and animal research. You will perform protocol pre-reviews and provide regulatory consultation to investigators to enhance IRB/IACUC approval likelihood.

Strong knowledge of DHHS, FDA, HIPAA, and related policies is essential, along with the ability to train staff and maintain documentation compliant with federal requirements.

Qualifikationen

• Bachelor’s degree required; Master’s degree preferred.
• Experience in regulatory oversight of human or animal research.
• Experience with IRB/IACUC processes is highly valued.

Aufgaben

• Provide expert-level knowledge of federal, state, and institutional regulations affecting human/animal research.
• Review complex research documents for ethical and regulatory issues.
• Guide researchers and staff on protocol submissions and regulatory reviews.
• Document decision processes in reviewer checklists and correspondence.
• Develop and maintain relationships with internal/external stakeholders.

Kenntnisse

Regulatory knowledge

IRB/IACUC familiarity

Clinical research environment

Ausbildung

Bachelor's Degree in related field

Master's Degree in related field preferred

Tools

CPIA or CIP certification

Jobbeschreibung

Job Description - Senior Regulatory Analyst, Human Research Protection IRB (977081)

Job Description

Senior Regulatory Analyst, Human Research Protection IRB - ( 977081 )

Description

WHY UT SOUTHWESTERN?

With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report , we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career!

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.

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.

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.

SECURITY AND EEO STATEMENT

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

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.

UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of: race; color; religion; national origin; gender, including sexual harassment; age; disability; citizenship; and veteran status. In addition, it is UT Southwestern policy to prohibit discrimination on the basis of sexual orientation, gender identity, or gender expression.

Copyright 2017.The University of Texas Southwestern Medical Center5323 Harry Hines Blvd., Dallas, Texas 75390Phone [phone]