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Clinical Research Coordinator III - Deep Brain Stimulation Therapies

Employer
University of Florida
Location
Florida, United States
Salary
Salary Not Specified
Posted date
Aug 17, 2021

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Position Type
Faculty Positions, Health & Medicine, Other Health & Medicine, Surgery, Administrative, Academic Affairs, Research Administration
Employment Type
Full Time
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Classification Title:

Clinical Research Coord III

Job Description:

The Norman Fixel Institute for Neurological Diseases at the University of Florida has an immediate opening for a dedicated Clinical Research Coordinator III to support the development of novel deep brain stimulation therapies. The Fixel Institute is an internationally recognized leader for developing innovative new therapies for patients with Tourette syndrome as well as other neurological and psychiatric disorders using a combination of computational research and human studies. The Clinical Research Coordinator III is responsible for managing and overall coordination of NIH funded protocols to test new therapies. This individual will be responsible for implementing good clinical practice guidelines and following federal guidelines and reporting requirements. Ensures that all regulatory requirements are responded to appropriately under strict deadlines. A compassionate and professional demeanor and ability to work with patients diagnosed with progressively disabling and/or terminal illnesses are essential.

Duties include:

  • Responsible for the daily operations of National Institutes of Health (NIH) funded clinical trials, including recruitment and enrollment of patients into the protocols and implementation of industry sponsored and grant funded research protocols. Must have a proficient knowledge of Food and Drug Administration (FDA), NIH, and federal and local policies in regards to research. Proficient in coordinating trials across multiple disciplines and study sites to ensure the successful completion of the trial which includes but not limited to scheduling research patients and coordinating research visits with provider schedules, administrative rules and policies, and coordinating across sites. Successfully executes multidisciplinary studies with investigators from multiple departments. Incumbent will be in charge of screening, administering questionnaires. Responsible for entering data into clinical trial management system (RedCap and Oncore) and sponsor-related data bases. Reports all adverse events to the Institutional Review Board (IRB). Works with the FDA to apply for and obtain Investigational Device Exemptions (IDE).
  • Responsible for administrative aspects of all investigator research, industry sponsored trials, and device clinical trials; interprets and explains contractual terms and conditions to investigators and staff; and assists investigators with meeting requirements of external regulatory bodies. Maintains data and filing system of completed, ongoing, and pending research protocols. Experience with the FDA to apply for and obtain Investigational Device Exemptions (IDE) and/or Investigational Drug (IND).
  • Promotes and facilitates enrollment and Tourette-related research at the Fixel Institute. Provides expertise and advice to faculty regarding the design of investigator (including scientists, fellows, and faculty) initiated research. Provides those listed above with information on sources of grant funding through federal, state, and private sector organizations/agencies for investigator-initiated research. Trains investigators and staff on protocol required training modules. Acts as a resource for investigators and research staff by answering questions and problem solving.
  • Regulatory management: Responsible for administrative aspects of all assigned investigator research as well as industry sponsored trials and device clinical trials; interprets and explains contractual terms and conditions to investigators and staff; and assists investigators with meeting requirements of external regulatory bodies. Maintains data and filing system of completed, ongoing, and pending research protocols.
  • Attends conferences/meetings as a representative of the Fixel Institute.
Expected Salary: $62,500 - $70,000; commensurate with education and experience Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience. Valid driver’s license for in-state travel as needed.

Preferred Qualifications: • Master’s degree or higher preferred.
• 3 or more years of human subject research experience.
• Experience with quantitative and qualitative research methods and analysis is a plus.
• Comprehensive knowledge of NIH and FDA procedures, state and federal regulations regarding clinical research, accepted procedures, and ethical, confidential practices
• Association of Clinical Research Professionals Certified Professional Certification (ACRP) or The Society of Clinical Research Associates (SOCRA) Certified Clinical Research Professional Certification, a plus Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume.

The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.

This is a time-limited position.

This requisition has been reposted. Previous applicants are still under consideration and need not apply.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Health Assessment Required: Yes

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