SENIOR INSTITUTIONAL REVIEW BOARD COORDINATOR

SENIOR INSTITUTIONAL REVIEW BOARD COORDINATOR

Posting Number: SRGV6405
Number of Vacancies: 1
Location: Rio Grande Valley
Department: Research Compliance and Export Control
FLSA: Exempt

Scope of Job:
To lead, manage, and provide complex support and oversee the review and approval process of all research activities involving human subjects to protect their safety, rights, and welfare in compliance with Institutional Review Board (IRB) regulations for the Human Subjects Protections Program.

Description of Duties:

• Ensures that all IRB applications being processed are compliant with governmental regulations, statutes, and University policies and procedures.
• Acts as a subject matter expert regarding IRB regulations and matters.
• Responsible for developing and delivering a training curriculum including education programs for PIs, IRB members, and IRB staff as well as training videos to add to the IRB website.
• Oversees, assists, and mentors assigned staff.
• Serves as a liaison for internal and external parties regarding IRB matters as needed.
• Manages all aspects of the collection and review of applications that involve human subjects in research.
• Manages and conducts pre-reviews of applications submitted to the IRB, including new study protocols, continuing reviews, and modifications to approved studies to ensure consistency with federal regulations, institutional policies, and IRB requirements.
• Provides expert guidance and professional support to the university’s Human Subjects Protections Program and communicates with the Institutional Review Board regarding the procedural and regulatory requirements of human subjects’ research.
• Oversees, reviews, assesses, and recommends to the IRB applications of studies that qualify for expedited review procedures versus full Board review.
• Ensures, assesses, reviews, and makes the determinations for non-regulated studies and studies that are deemed exempt from federal regulatory compliance.
• Reviews and processes reliance agreements for multi-site research; conducts local review for studies approved by a non-UTRGV IRB.
• Oversees and conducts pre-review of unanticipated problems and adverse events and makes recommendations to management.
• Responsible for in the identification of potential regulatory issues with human subject research protocols, provides technical support and procedural guidance to regulatory or compliance staff, investigators, and the IRB members.
• Oversees and conducts literature reviews and prepares reports for the IRB regarding scientific, ethical, and existing and proposed regulatory topics.
• Executes directives resolved by the IRB, including drafting and execution of determinations and applicable compliance findings or action items.
• Manages and coordinates quality control functions and assists in post-approval monitoring.
• Plans and coordinates IRB meetings: attends meetings and actively participates in discussions; records Board deliberations by writing and editing meeting minutes.
• Provides regulatory expert support to the IRB members.
• Collaborates with other regulatory committees for ancillary review.
• Develops and maintains templates to assist researchers with their study submissions to the IRB.
• Liaises with researchers to revise submissions and prepare for final board review.
• Ensures and maintains accurate records are kept for IRB matters.
• Performs other duties as assigned.

Supervision Received:
General supervision from assigned supervisor.

Supervision Given:
Direct supervision of assigned staff.

Required Education:
· Master’s degree in business administration, healthcare, scientific field, public health or a directly related field from an accredited university, ora Bachelor’s degree in the required field with five (5) years of the required experience. 

Preferred Education:
None.

Licenses/Certifications:
Certified IRB Professional (CIP) or obtain certification within 2 years from hire.

Required Experience:
Three (3) years of experience conducting IRB reviews or conducting human subjects’ research in a regulated environment.

Preferred Experience:
Experience with electronic IRB processes; experience reviewing biomedical protocols, including FDA covered protocols; experience with central/single IRB processes and reviews.

Equipment:
Use of standard office equipment.

Working Conditions:
Needs to be able to successfully perform all required duties. Office Environment; some travel and weekend work is required. Exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. UTRGV is a distributed institution, which requires presence at multiple locations throughout the Rio Grande Valley. Work is performed primarily in a general office environment and can be performed remote. If the work is performed remote, high-speed internet and a designated workspace are required.

Other:
Ability to work in a dynamic environment under pressure and critical thinking skills. Knowledge of complex federal, state, local and university regulations regarding human subjects research. Understanding of research ethics and compliance, as well as terminology. Ability to interpret regulations, policies, and procedures as relates to human subjects research and other aspects of research compliance. Ability to apply regulatory review criteria to incoming protocol applications. Ability to multi-task in a deadline driven environment. Ability to communicate effectively verbally and in writing.

Physical Capabilities: N/A
Employment Category: Full-Time
Minimum Salary: Commensurate with Experience
Posted Salary: Commensurate with Experience
Position Available Date: 12/21/2022
Grant Funded Position: No
If Yes, Provide Grant Expiration Date:

EEO Statement:
It is the policy of The University of Texas Rio Grande Valley to promote and ensure equal employment opportunities for all individuals without regard to race, color, national origin, sex, age, religion, disability, sexual orientation, gender identity or expression, genetic information or protected veteran status. In accordance with the requirements of Title VII of the Civil Rights Act of 1964, the Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, and the Americans with Disabilities Act of 1990, as amended, our University is committed to comply with all government requirements and ensures non-discrimination in its education programs and activities, including employment. We encourage women, minorities and differently abled persons to apply for employment positions of interest.

Special Instructions to Applicants:
Dear Applicant, Human Resources will not be held responsible for redacting any confidential information from the documents you attach with your application. The confidential information includes the following: *Date of Birth *Social Security Number *Gender *Ethnicity/Race Please make sure that you omit this information prior to submission. We are advising that Human Resources will be forwarding your application to the department as per your submission. If you have any questions, please do not hesitate to contact us at (956)665-8880 and/or careers@utrgv.edu.

Additional Information:
UTRGV is a distributed location institution and working location is subject to change based on need.

All UTRGV employees are required to have a criminal background check (CBC). Incomplete applications will not be considered.

Substitutions to the above requirements must have prior approval from the Chief Human Resources Officer.

To apply, visit https://careers.utrgv.edu/postings/36997 jeid-b34c99291fc81747b045dff6f6ffbaf5