Overview JOB DUTIES Assist in the conduct and coordination of clinical trials by insuring compliance with clinical protocol requirements, institutional and federal guidelines and department procedures under the direct supervision of the manager. Essential Functions • Assists with screening and consenting potential participants interested in research clinical studies. Tracks required patient visits and coordinators scheduling with front desk. • Adheres to ongoing clinical trial protocol-specific procedures as well as good clinical practice and departmental standard operating procedures. • Assists Coordinators with maintaining monthly billing for study visits and documents appropriate fees on research referral forms. Assists Coordinators with the collection of data from patient charts, medical records, interviews, questionnaires and other sources, and in the overall conduct of research studies. • Assists with organization and preparation of study start-up documents, protocol worksheets, and regulatory document forms. Maintains clinical trial documents and regulatory binders; files and archives as needed. Maintain accurate documents including medical licenses, CV’s. • Completes, submits and organizes Case Report Forms. Maintain tracking logs for all research regulatory documents including new protocol submission, annual renewals, safety reports, invoices, brochures, etc. Assist with the preparation of initial institutional review board (IRB) submissions, collect and maintain data forms for various studies. Ensures that all IRB files are current and kept secured. • Perform audits/quality review of regulatory files, case report forms, informed consents, and other study related material and/or tracking logs. • Searches national database and creates specific databases, data collection forms, and tracking forms for research purposes. • Coordinate and implement research efforts of departmental faculty. Assists faculty with navigating technological and software applications. • Sets up visits with study monitors; prepares regulatory documentation for visit; interacts with study monitor during visit to ensure that regulatory documents are accurate and complete. • Performs phlebotomy and completes all study lab processing including centrifuging, packaging, shipping, and storage. Qualifications SKILLS, QUALIFICATIONS, AND REQUIRED EXPERIENCE Skills, Knowledge, Abilities • Computer literate with proficiency in Microsoft Office (Outlook, Word, Excel, Access, and Power Point), Adobe Acrobat, 10-key, and database management. • Possesses critical thinking, prioritization, and organizational skills. • Capacity to conduct literature searches and evidence-based reviews. • Knowledge of research process and statistical analysis. • Possesses critical thinking, prioritization, and organizational skills. • Demonstrated self-motivation, ability to work independently with particular attention to detail and accuracy. • Ability to effectively work under pressure in order to meet deadlines. • Ability to manage multiple priorities and meet deadlines. Experience Requirements Length of Experience Type of Experience Required/Preferred 1 year Professional experience required 2 years Experience in research regulatory experience strongly recommended preferred Education Requirements Degree/Diploma Obtained Program of Study Required/Preferred Bachelors Health Sciences, Public Health, Research and Statistics preferred Additional Details: **********Certified Medical Assistant: Certification must be maintained and current*********** UFJPI is an Equal Opportunity Employer and Drug Free Workplace