Job Summary:

The Research Compliance 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.

Duties & Essential Job Functions:

1. Performs an administrative pre-review of Biosafety, IRB and IACUC protocols for completeness, consistency, and compliance. Resolves administrative discrepancies and deficiencies prior to committee review
2. Organizes, files and tracks new and annual review dates for all research protocols submitted to the IRB, IACUC, and Biosafety Committees.
3. Ensures IRB protocols addresses any social, physical, legal, and economic risk to potential participants.
4. Reviews IRB and IACUC protocols for statistical analysis to ensure the correct statistical principles are applied to the research proposal and determination of group sizes.
5. Develops, cultivates, and maintains working relationships with internal/external departments/agencies and other organizations associated with and/or receiving benefit from the research program.
6. Creates and maintains files in SharePoint for all areas related to the responsibilities of the Research Compliance Manager. Writes correspondence to PIs to communicate the decisions of the IRB, IACUC, Biosafety, and Laser Safety committees; amendments and continuing review forms, and prepare recommendations to the committee; prepares approval letters and consenting materials; Stamps all protocols and consents with appropriate study numbers and approval dates. Recommends new policies and procedures for improvement of program activities. Advises investigators on proposed ethical practices, patient safety, and patient rights; facilitates approval by the IRB; assesses risk and channels applications to one of three levels of review and IRB oversight (Exempt, Expedited or Full Board). 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.
7. Assist Office of Research Compliance leadership with budget review as it relates to economic analysis on an annual basis prior to the new fiscal year.
8. Performs other duties as assigned.

Required Education & Experience:

• Bachelor’s degree in Economics.
• 1 year of experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).

Preferred Education & Experience:

• Master’s degree.
• 2 years of experience providing direct administration or management of a regulated research program at a university (e.g., human subjects, animals, biosafety).

Required Licensure/Certification/Specialized Training:

• None.

Preferred Licensure, Certification, and/or Specialized Training:

• 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, Skills & Abilities:

• 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.

TCU Core Competencies:

University Core Competencies definitions may be found on the Human Resources website and in the staff performance management system.

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.
• This is an in-person, on-campus role.

AA/EEO Statement:

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.