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Clinical Research Coordinator III - Amyotrophic Lateral Sclerosis (ALS)

Employer
University of Florida
Location
Florida, United States
Salary
Salary Not Specified
Date posted
Mar 24, 2022


Classification Title:

Clinical Research Coord III

Job Description:

The Department of Neurology, Division of Neuromuscular is seeking experienced candidates for a Clinical Research Coordinator III position. The Clinical Research Coordinator III is responsible for the daily operations of clinical trial studies run by the Neuromuscular Division. Responsible for ensuring that all required regulatory documentation is completed and submitted as appropriate for all research/clinical trial activity which includes, but is not limited to, new submissions, continuing reviews, and revisions through the University of Florida Health Professions IRB and a central IRB.

Duties to include:

Responsible for the daily operations of studies run by the Department of Neurology. The predominant research focus for this position will be studies pertaining to Amyotrophic Lateral Sclerosis (ALS). ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Studies in other neuromuscular diseases will be included based on division need

Successfully executes multidisciplinary studies to include biomarker studies, Phase I to post-market research with investigators from multiple departments. Current studies are administered in outpatient clinics at the Fixel Center for Neurological Diseases as well as at the UF Clinical Research Center (CRC). The potential for inpatient studies exist. Job expectations include being present and available at the ALS clinic to screen and recruit for studies. Once subjects are identified, in charge of recruiting patients for the various studies; in charge of screening, administering questionnaires, as well as giving standardized cognitive and motor tests. Must work well as part of a team and understand the need for flexibility to adapt to changing environments. Enters data into clinical trial management systems and 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 should be familiar with the contractual terms and conditions; and assists investigators with meeting requirements of external regulatory bodies. Maintains data and filing system of completed, ongoing, and pending research protocols.

Promotes and facilitates both clinical and basic science research for the in the Department of Neurology in conjunction with the College of Medicine (COM). Provides expertise and advice to faculty and the department 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, fellows and staff regarding the research design, regulatory requirements, and methodology process. Acts as a resource for investigators and research staff; answering questions and problem solving.

Attends research study conferences and meetings as a representative of the Department of Neurology.

Gainesville is a vibrant city in Alachua County and serves as the cultural, educational and commercial center for the north central Florida region. The city is known for its nature parks, sport events, museums, mild winters and warm summers, and central location for day trips to beaches along the Atlantic Ocean and Gulf of Mexico, theme parks including Disney World, and other cities including Orlando and Tampa.

Expected Salary:

$60,000 - $70,000

Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

Preferred Qualifications:

3 years or more of human subject research/clinical trials experience.
Comfortable working with vulnerable patient population with terminal illnesses.
Advanced knowledge of accepted procedures and ethical, confidential practices.
Demonstrated ability to problem-solve; to manage multiple priorities; to be reliable.
Possess strong organizational and time management skills; adhere to study deadlines.
Proven ability to work as part of a team, as well as independently.
Excellent interpersonal and communication skills including written and oral expression.
Knowledge of NIH and FDA procedures.
Knowledge of state and federal regulations regarding clinical research.

Special Instructions to Applicants:

In order to be considered, you must upload your cover letter and resume. Please include 3 to 5 professional references within the application.

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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