Full job description Under the direction of the IRB Administrator and in cooperation with the Institutional Review Board (IRB) Chair, the Specialist has a vital role in ensuring a high-quality human subjects' protection program that reflects The University of Texas at El Paso's commitment to the ethical conduct of research involving human subjects. In this role, the incumbent is responsible for the administrative management of research compliance and of the activities of the IRB. With minimal supervision, provides coordinating services, keeps official records, and executes administrative policies determined by or in conjunction with other officials, within area of assigned responsibility.
Essential Functions Provide technical pre-review of incoming IRB protocols for preliminary determination of completeness and regulatory compliance. Work constructively with investigators to revise protocols, as needed. Consult with IRB Administrator/Manager/Executive Director as needed to ensure accuracy of pre-review in complex cases.
Conduct congruence analysis to ensure that proposed human subject activities are consistent with the associated funding application.
Advise, assist, and provide education in individual and group settings to investigators regarding appropriate procedures for submitting new protocols, amendments, requests for continuance and closing reports.
Coordinate and relay all review-related correspondence to investigators, including reviewer comments, IRB determinations, and requests for additional information.
Provide high-level support, data entry and training support to the IRB area.
Triage all incoming IRB correspondence, phone queries and other communications. Draft written responses when needed, including researching relevant regulations and other related information as required or requested.
Assist with compiling agenda items and researching/summarizing relevant background information to facilitate discussion and inform decision-making. Record meeting minutes and facilitate their approval.
Review and compile protocol submissions, tracking protocol turnaround times and generate data and statistics for quality assurance and improvement initiatives.
Assist with administrative duties related to drafting reports of non-compliance, required periodical reports to governing agencies, as well as managing and reviewing data entry to
Review and update internal SOP's and IRB websites as needed.
May coordinate and schedule IRB meetings, send invitations, ensure quorum and that all meeting information has been distributed for members.
Ensure protocols are renewed prior to expiration and all training requirements have been met.
Assist with document revision/preparation, maintenance, and creation of proper forms for investigators to use.
Identifies areas of needed change and makes recommendations to improve operations.
Work closely, cooperatively, and professionally with other staff members, and coordinate efforts with the Division as a whole, including providing coverage as needed.
Engage in professional development opportunities as available; maintain memberships in professional listservs and regularly review postings to gain updated information about relevant regulations and best practices and apply them to IRB materials and procedures.
May represent the business function, division, or department at meetings, conferences, and seminars or committees.
Knowledge of all Microsoft Office software and able to learn and use institutional software systems.
Complies with all State and University policies.
Other duties may be assigned.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Required Qualifications: Education: Bachelor's Degree
and Experience: Two (2) years of related experience and/or training to the essential duties and responsibilities. Equivalent combination of education and experience will be considered.
Occasional traveling is required.
Applicants Should Demonstrate: Strong verbal and written communication skills
Additional Information The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee must frequently stand and walk. The employee must regularly sit; use hands to feel; reach with hands and arms; and talk or hear. Special vision requirements are close vision and color vision.
The noise level for this work environment is moderate.
In keeping with its access, excellence and impact mission, The University of Texas at El Paso is committed to an open, diverse, and inclusive learning and working environment that honors the talents, respects the differences, and nurtures the growth and development of all. We seek to attract faculty and staff who share our commitment.
The University of Texas at El Paso is an Equal Opportunity / Affirmative Action Employer. The University does not discriminate on the basis of race, color, national origin, sex, religion, age, disability, genetic information, veteran status, or sexual orientation and gender in employment or the provision of services in accordance with state and federal law. Discrimination on the basis of sex includes an employee's or prospective employee's right to be free from sexual harassment under Title IX of the Higher Education Amendments of 1972.
For accommodation information for employees and applicants with disabilities, please contact UTEP's Equal Opportunity Office at .
