Job Description

The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

Under the supervision of the IRB Manager, the IRB Coordinator provides regulatory expertise, guidance and administrative support to the Institutional Review Board(s) (IRB). The IRB Coordinator is responsible for processing submissions according to the policies and procedures outlined in the HRPP Toolkit and serves as a regulatory resource to support IRB review. The IRB Coordinator has the primary responsibility of moving submissions through the OHSP workflow in a timely manner, ensuring that submissions are review ready prior to routing for review, conducting certain non-committee reviews, and generating correspondence after the review process is complete. The IRB Coordinator is also responsible for managing the activities of IRB committees, including developing agendas and writing minutes and ensuring appropriate regulatory determinations are made during convened meetings

JOB SPECIFIC COMPETENCIES

Serve as IRB Resource

Serve as a resource to IRB Members, researchers, and key personnel by providing support for the preparation of research applications, including guidance on applicable regulations, and submission in the electronic IRB submission system.

Process Submissions to the OHSP

Process submissions to the OHSP as assigned, including New Studies, Modifications, Continuing Reviews, and Reports of New Information a) Conduct pre-review to ensure that submissions are review ready)

Route submissions appropriately for either non-committee or committee review)

Communicate review results to investigators and others as needed

Coordinate IRB Activities

Coordinate IRB activities including expedited and full-board reviews

Assist with Human Research Policy Review

Assist with the review, implementation and communication of policies, procedures, documents and correspondence related to research with human participants

Maintain IRB Documentation

Maintain documentation of IRB decisions, related correspondence, proposal approval and records management

IRB Research Community Contact Person

Serve as the primary contact for the research community on issues of human subjects research
Provide Compliance Training and Education
Provide training and education to researchers in compliance related areas

Quality Assessment and Improvement

Participate in quality assessment and improvement activities
Coordinate IRB Meetings
Prepare for, coordinate, and facilitate IRB Committee meetings, which includes, but is not limited to, the following:

a) Prepare submissions for review by the convened IRB

b) Assign reviewers to submissions)

Create IRB meeting agendas, manage volume, expected quorum and expertise d)

Confirm IRB member meeting attendance to ensure quorum e)

Monitor quorum during IRB meetings f)

Document determinations made by the convened IRB g)

Generate IRB meeting minutes and correspondence h)

Provide regulatory guidance to the IRB Chair and members i)

Review submissions in order to anticipate regulatory issues for which IRB members may need assistance (e.g., IND/IDE questions)

Other duties as assigned

Education
Required: Bachelor's degree.

Experience
Required: One year of experience in IRB administration, clinical research or human subject protection, regulatory compliance or research related job. May substitute required education with related human subjects protection and/or research administrative experience on a one to one basis.

Certification/Licensure
Required: Certified IRB Professional (CIP) from the Public Responsibility in Medicine and Research (PRIM&R) within 180 days of eligibility.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

Additional Information

• Requisition ID: 160933
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 54,500
• Midpoint Salary: US Dollar (USD) 68,000
• Maximum Salary : US Dollar (USD) 81,500
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Soft
• Work Location: Remote (within Texas only)
• Pivotal Position: Yes
• Referral Bonus Available?: Yes
• Relocation Assistance Available?: Yes
• Science Jobs: No

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