Responsible for tasks related to implementing and completing clinical trials. Maintains knowledge of study protocols. Assists in the daily operations of the recruitment under the direction of the Principal Investigator and Co-Investigators.
Will manage and coordinate patient related tasks of Cardiology/Electrophysiology patients participating in clinical trials. Able to work on clinical studies which require a high level of understanding, ability to multi-task and process all sponsor requests for study revisions and required reporting. Works with a high degree of independence in performance of functions.
Specific Duties & Responsibilities:
Recruits, instructs, and coordinates research subjects , as appropriate, to specific study objectives and work scope.
oSchedules study follow-up visits and research related tests to ensure that subjects are seen in the study window timeframe to minimize protocol deviations.
Implements and maintains data collection and analysis systems in support of research protocol; including the management of data, paper files, subject binders and electronic databases.
Ensures the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.
Acts as the primary administrative point of contact for internal research staff
Coordinates the day-to-day activities in the carrying out of research protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives.
Develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators and/or regulatory bodies.
oAssists with reporting protocol deviations and adverse events in a timely manner.
oAssists with maintaining study inventory according to regulatory standards.
Works with Compliance Committees and Institutional Review Boards. Assists with IRB submissions/applications. Prepares and maintains IRB and other regulatory documentation for multiple projects.
Maintains compliance with Good Clinical Practice Guidelines, ICH Guidelines, IRB requirements and Federal Regulations pertaining to research.
Performs miscellaneous job-related duties as assigned.
Bachelor's degree in related discipline
Some related experience
Additional education may substitute for required experience and additional related experience may substitute for required education, to the extent permitted by the JHU equivalency formula
Research experience preferred. Ability to prioritize and coordinate multiple tasks. Ability to work well and communicate effectively with others. Strong organizational skills, attention to detail, be able to work independently and as part of a team, initiative, strong leadership skills, and an ability to work with a team of researchers and with diverse subject populations. Excellent oral and written communication skills. Working knowledge of PC operations and software applications such as MS Windows, Excel, Word, and Access required. Ability to learn new database and software applications is required. Ability to follow multiple, detailed directions of various protocols. Knowledge of medical terminology highly desired. Excellent time management skills.
Classified Title: Research Program Coordinator Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: Commensurate with experience Employee group: Full Time Schedule: M-F 8:00am - 4:30pm Exempt Status: Non-Exempt Location: School of Medicine Campus Department name: SOM DOM Cardiology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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