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000387.html

UNIVERSITY OF LOUISVILLE
Professional/Administrative Job Specification 
(3/97)



JOB TITLE: Clinical Trials Coordinator
CLASS CODE: 000387  

JOB SUMMARY

Work independently to coordinate all aspects of clinical research trials, including protocol compliance, exams and procedures, education of subjects, study medication dispensing, etc. Act as liaison between sponsors, investigators and I.R.B. Submit necessary documents to I.R.B. and insure proper compliance throughout study. Prepare budgets, arrange payment for patients, as well as for the bills that they incur.

DUTIES AND RESPONSIBILITIES

Correspond with I.R.B. and sponsor to initiate study, implement changes, revisions, and/or amendments, to the protocol, consent form, budget etc.

Recruit, screen, manage, educate and coordinate eligible study patients regarding protocol adherence, compliance, study-related procedures, deviations from protocol, etc.

Collect, assess and monitor various test results and patient complaint and use judgment to decide what should be followed-up and what conditions require further intervention.

Communicate with and assist OB/GYN staff at three separate locations, various hospitals, departments, (billing, radiology, Pathology etc.) investigators outside facilities, (dry ice) among others, to conduct studies.

Meet regularly with study monitors to assess and review case report form books, drug accountability, patient recruitment & enrollment.

Attend investigator and study initiation meetings to initiate studies.

Prepare necessary paperwork to facilitate proper progress throughout study.

Procure payment (stipend) for study patients. Create and maintain billing ledger documenting all invoices sent to administrative department to be paid. Communicate with individuals regarding billing matters.

Assist doctors, residents, Nurse practitioners with patient exams, collect and ship various specimens.

KNOWLEDGE, TRAINING AND SKILLS

Bachelor's degree in a related field.

EXPERIENCE

One year related experience. Additional related experience may be substituted for up to two years of education.


The intent of this document is to provide a representative summary of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented.

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