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IRB Coordinator

Location: Fort Worth, TX
Job # 11735985
Date Posted: 12-16-2018
Job Summary:
Under immediate supervision of the Director of Research Compliance, the Institutional Review Board ("IRB") Coordinator will oversee the human subjects research protocol submission workflow to help ensure that the TCU IRB conducts reviews of submitted human subject research applications in accordance with federal requirements, and TCU policies and procedures. Specifically, the IBR Coordinator will work with personnel in all areas of the submissions and review process to ensure appropriate preview of all protocols applications and consent forms; track and prepare monthly reports of submission status; database entry and generating written feedback letters to investigators; and provide support to faculty and research staff on research submissions, training requirements, and updated processing procedures. This position will be expected to work closely with the IRB Chairperson.
Duties and Essential Job Functions:
Coordinates regulatory committee review of human subjects and protocols through email and the TCU electronic protocol submission tracking system (InfoEd).
Performs an administrative pre-review of IRB protocols for completeness, consistency, and compliances. Resolves administrative discrepancies and deficiencies prior to committee review.
Organizes, files, and tracks all IRB protocols.
Prepares correspondence to principal investigators to communicate the decisions of the IRB.
Performs other related duties as assigned.  
Position Requirements:
Required Education and Experience:
Bachelor's degree or 2 years' experience providing direct administration of a human subjects research IRB conducting active research protocols.
Preferred Education and Experience:
Bachelor's degree.
2 years' experience providing direct administration of a human subjects research IRB conducting active research protocols.
Knowledge, Skills & Abilities:
Knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations for human subject research.
Knowledge of a research program that includes: protocol preparation, processing for approval, and continuing review; methods of communication with investigators, with command, and with higher headquarters and outside agencies; protocol tracking and data storage; and consent form regulations.
Skill in basic computer programs (i.e. Microsoft Office Suite) and ability to with complex databases.
Skill in customer service.
Skill with analytics and problem solving.
Ability to plan, meet deadlines, work under pressure, and organize multiple projects or tasks.
Ability to communicate effectively, both orally and in writing.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Ability to effectively support the IRB and contribute to working groups, staff meetings, and other committees as assigned.
Ability to be flexible and adapt.
Physical Requirements (With or Without Accommodations):
Visual acuity to read information from computer screens, forms and other printed materials and information.
Able to speak (enunciate) clearly in conversation and general communication.
Hearing ability for verbal communication/conversation/responses via telephone, telephone systems, and face-to-face interactions.
Manual dexterity for typing, writing, standing and reaching, flexibility, body movement for bending, crouching, walking, kneeling and prolonged sitting.
Lifting and moving objects and equipment up to 10 lbs.
Work Environment:
Work is indoors and sedentary and is subject to schedule changes and/or variable work hours.
There are no harmful environmental conditions present for this job.
The noise level in this work environment is usually moderate.
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Gyna M. Bivens
President & Executive Director
North Texas LEAD

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