The Research Compliance QA (Quality Assurance) Coordinator will assist with regulatory compliance for the research enterprise of TCU, and will perform protocol pre-reviews prior to submission to the IRB, IACUC, and IBC. Provide consultation to the TCU research community on regulatory and policy issues.
1. Assists Research Compliance Manager in the development and implementation of Quality Assurance program for the Office of Research Compliance.
2. Conducts routine and for-cause audits to ensure research is being conducted in accordance with federal regulations governing the protection of research participants, TCU policies and procedures, and good clinical practice (GCP) guidelines across all applicable compliance programs.
3. Organizes, files and tracks post approval monitoring activities for all research protocols approved by the TCU IRB, IACUC, and Biosafety Committees.
4. Performs quality assurance reviews of TCU compliance staff and committees meeting minutes to ensure regulatory compliance
5. Performs administrative pre-review(s) of Biosafety, IACUC and IRB protocols for completeness, consistency, and compliance. Resolves administrative discrepancies and deficiencies prior to committee review.
6. Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
7. Recommends new policies and procedures for improvement of program activities. Advises investigators on proposed ethical practices, patient safety, and patient rights; Assists Research Compliance Manager in developing, recommending, training, and implementing policies and procedures in compliance with university and federal requirements to enhance efficiency of committee operations and general office functions.
8. Performs other duties as assigned.
• Bachelor’s degree.
• 2 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).
• 2 years’ experience in a role requiring strong coordination skills; e.g., organization, communication, analysis (experience can run concurrently).
• Master’s degree.
• 3 years’ experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).
• National Association of IRB Leaders (NAIM) Certification, Certified IRB Manager (CIM), Public Responsibility in Medicine and Research (PRIMR) Certified IRB Professional (CIP), Registered Biosafety Professional (RBP), Certified Biosafety Professional or Certified Professional in IACUC Administration (CPIA) or the ability to qualify within one year of hire date.
• Knowledge of QA principles and theories.
• Skill in verbal, written, and interpersonal communication to work effectively with all levels of staff, faculty, and scientists. Knowledge of medical terminology and treatment concepts.
• Skill in using desktop and networked computer software, to include intermediate or advanced level competencies with Microsoft Windows and the Microsoft Office suite (Outlook, Word, Excel).
• Ability to provide technical assistance and consultation to faculty and student researchers and other scientists.
• Ability to review, recommend, develop, and implement policies.
• Ability to apply leadership skills, assume responsibility and function under minimum supervision.
• Ability to be customer service oriented.
University Core Competencies definitions may be found on the Human Resources website and in the staff performance management system.
• 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 is indoors and sedentary and is subject to schedule changes and/or variable work hours.
• Work may require walking across campus or commuting to medical school site to conduct audits or provide education.
• This role is an on campus, in-person position.
• There are no harmful environmental conditions present for this job.
• The noise level in this work environment is usually moderate.
As an AA/EEO employer, TCU recruits, hires, and promotes qualified persons in all job classifications without regard to age, race, color, religion, sex, sexual orientation, gender, gender identity, gender expression, national origin, ethnic origin, disability, genetic information, covered veteran status, or any other basis protected by law.
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