INSTITUTIONAL REVIEW BOARD COORDINATOR
Full Time
McAllen, TX 78503
Posted
Job description
Number of Vacancies
1
Location
McAllen, Texas
Department
Research Compliance and Export Control
FTE
1.0
FLSA
Exempt
Scope of Job
To coordinate, provide 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
- Coordinates all aspects of the collection and review of applications that involve human subjects in research.
- Conducts pre-reviews of applications submitted to the IRB, including new study protocols, continuing reviews, and modifications to approved studies to determine consistency with federal regulations, institutional policies, and IRB requirements.
- Provides 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.
- Plans, reviews, assesses, and recommends to the IRB applications of studies that qualify for expedited review procedures versus full Board review.
- Assesses, reviews and makes determinations for non-regulated studies and studies that are deemed exempt from federal regulatory compliance.
- Coordinates and processes reliance agreements for multi-site research; conducts local review for studies approved by a non-UTRGV IRB.
- Conducts pre-review of unanticipated problems and adverse events and makes recommendations to management.
- Assists 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.
- 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.
- Coordinates quality control functions and conducts post-approval monitoring.
- Coordinates IRB meetings: attends meetings and actively participates in discussions; records Board deliberations by writing and editing meeting minutes.
- Provides regulatory support to the IRB members.
- Collaborates with other regulatory committees for ancillary review.
- Develops and delivers relevant education programs to researchers and IRB members.
- 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.
- Performs other duties as assigned.
Supervision Received
Specific supervision from assigned supervisor.
Supervision Given
Direct supervision of assigned staff.
Required Education
Bachelor’s degree from an accredited university in business, administration, healthcare, scientific field, public health or a directly related field.
Preferred Education
Master’s degree in a related area.
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
or Master’s degree and one (1) year of the required experience.
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
03/01/2023
Grant Funded Position
No
If Yes, Provide Grant Expiration Date
Posting Detail Information
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.
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.
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.
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