Clinical Research Coordinator III
- 508919
- Fort Worth, Texas, United States
- Staff
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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:
Welcome to the University of North Texas System. The UNT System includes the University of North Texas in Denton and Frisco, the University of North Texas at Dallas and UNT Dallas College of Law, and the University of North Texas Health Science Center at Fort Worth. We are the only university system based exclusively in the robust Dallas-Fort Worth region. We are growing with the North Texas region, employing more than 14,000 employees, educating a record 49,000+ students across our system, and awarding nearly 12,000 degrees each year.
We are one team comprised of individuals who are committed to excellence, curiosity and innovation. We are transforming lives and creating economic opportunity through education. We champion a people-first values-based culture where We Care about each other and those we serve. We believe that we are Better Together because we foster an inclusive environment of respect, belonging, and access for all. We demonstrate Courageous Integrity through setting exceptional standards and acting in the best interest of our communities. We are encouraged to Be Curious about opportunities for learning, creating, discovering, and innovating, and are encouraged to learn from failure. Show Your Fire by joining our team and exhibiting your passion and pride in your work as part of our UNT System team.
Learn more about the UNT System and how we live our values at www.UNTSystem.edu.
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.
