Title: Clinical Research Coordinator III

Employee Classification: Clinical Research Coord III

Campus: University of North Texas - Health Science Center

Division: HSC-Div of Rsrch & Innovation

SubDivision-Department: HSC-Health Institutes & Centers

Department: HSC-Inst Translational Research-304700

Job Location: Fort Worth

Salary: Commensurate with experience

FTE: 1.000000

Retirement Eligibility:

About Us - Values Overview:

Department Summary

The Institute for Translational Research is devoted to bringing novel diagnostics and interventions to patients and families suffering from neurodegenerative diseases, fostering translational research in neurodegenerative diseases at UNTHSC, and Create solutions for a healthier community. Our team spans basic "bench-top" science, clinical research, community-based research and clinical trials. Our translational approach is intended to foster discovery and expedite those discoveries toward the benefit of those suffering from brain disease. A particular emphasis of ITR is the development of personalized (or person-focused) medicine for Alzheimer's disease.

Position Overview

This role will manage and oversee the clinical research studies regulatory compliance, multiple projects and the submissions for the Institute for Translational Research and provide will high level support to the ITR Executive Director and Associate Director.

Minimum Qualifications

Bachelor's degree and four (4) years related experience; or equivalent combination of education and experience.

Knowledge, Skills and Abilities

* Strong oral and written communications skills
* Knowledge of policies, practices, procedures and terminology of assigned function
* Ability to establish and maintain effective working relationships
* Ability to conceptualize, plan and organize multiple programs and assignments effectively
* Ability to maintain complex records; to assemble and organize data of complex nature; and to prepare and submit reports in professional formats
* Ability to work independently
* Ability to work under pressure and to adjust to constant changes
* Considerable knowledge of Microsoft Office Suite
* Strong problem solving skills and critical thinking skills

Preferred Qualifications

Required License/Registration/Certifications

Job Duties:

•  Ensure ITR research study conduct is in compliance with all applicable local, state, and federal regulations, statutes, and laws, and complies with agencies including local and external IRBs, and the Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP), Participant confidentiality (HIPAA) and any other applicable laws and guidelines 
•  Manage all aspects of the CSF substudy of HABS HD to include IRB management, recruitment, prescreening, consenting, scheduling, clinical oversight ,assisting with and supervision and training of clinical personnel and procedures, collection of metrics and any other task required for successful study completion 
•  Coordinate the reporting of serious adverse events, protocol deviations, adverse drug reactions, and unanticipated problems as needed to all applicable agencies for assigned studies 
•  Managing regulatory submissions for FDA regulated research for IND (Tau PET scan study) to both LMI and FDA as well as local IRB. To include safety reporting to the FDA, sponsors, local and external IRB’s 
•  Oversight of assigned human subject research study submissions 
•  Manage clinical trial regulatory submissions to sponsors and both local and external IRB’s. Supervision and training of clinical personnel. Manage study drugs (if applicable); oversight of clinical (medical)/safety protocols for ITR 

Work Schedule:

Monday- Friday 8a-5p On Site

Driving University Vehicle:

No

Security Sensitive:

This is a Security Sensitive Position.

Special Instructions:

Benefits:

For information regarding our Benefits, click here.

EEO Statement:

The University of North Texas System is firmly committed to equal opportunity and does not permit -- and takes actions to prevent -- discrimination, harassment (including sexual violence) and retaliation on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, genetic information, or veteran status in its application and admission processes, educational programs and activities, facilities and employment practices. The University of North Texas System immediately investigates complaints of discrimination and takes remedial action when appropriate. The University of North Texas System also takes actions to prevent retaliation against individuals who oppose any form of harassment or discriminatory practice, file a charge or report, or testify, assist or participate in an investigative proceeding or hearing.