Clinical Research Coordinator II (located on Main Campus)
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POST DATE 9/13/2016
END DATE 12/13/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONUnder the general direction of the Principal Investigator(s), the Clinical Research Coordinator II is responsible and accountable for coordinating and implementing specific aspects of designated research protocols as part of a research team. Individual provides all aspects of protocol management, including patient eligibility screening, ensuring protocol compliance, reporting of adverse reactions, monitoring subject treatment, specimen collection and maintenance of accurate and complete clinical research files.
Duties include those of a Clinical Research Coordinator I, with additional responsibilities such as:
Works with principal investigators, research coordinators, and other study staff to identify and screen appropriate candidates for protocols and evaluates criteria for inclusion/exclusion per study protocol. Obtains all necessary approvals including written subject informed consent, and demographic information required for subject enrollment. Arranges and coordinates scheduling of initial assessment and subsequent assessments, if necessary, as outlined in study protocol.
Collects samples and arranges transport of samples for processing. Collects, analyzes and assures the quality of pertinent subject documentation according to established guidelines. Maintains confidential subject files, all correspondence, patient information, applicable data and follow-up status of all study subjects. Documents and maintains specific protocol information and communications according to the established guidelines of the unit.
Monitors study by gathering information and reviewing materials, visiting subjects in the study, discussing problems and exchanging information with study team.
Collects, compiles, tabulates and analyzes research data. Ensures data is entered accurately and in a timely fashion. Reviews and analyzes significant data and pertinent statistics. Works to ensure appropriate control systems are in place to monitor the progress of data acquisition and to define new approaches to data management. Periodically assess quality and completeness of database and subjects' files. Maintains all required records. Serves as a resource in analyzing and providing statistical information.
Organizes, establishes and maintains research databases and extracts information for reports, papers and feedback to the study team.
Assesses learning needs and educates subjects and family as appropriate regarding protocol management and participation in research project.
Organizes and participates in project team meetings, prepares the agendas, etc.
Assesses subject participation on a continuous basis and acts as liaison between subject and other members of the team regarding the research protocol.
On a monthly basis, verifies applicable patient care costs are billed appropriately to the study and/or the patients insurance and works with the Administrative Director to submit patient care charge corrections when needed.
Establishes effective working relationships with the project team. Contacts subjects and/or families via written and telephone communications for the purpose of explaining the nature of the study and setting up visits and interviews.
Assists with the training and orientation of new staff.
Bachelors degree required in a science or healthcare related field
At least 1 year of directly relevant experience (patient care experience).
Ability to effectively function independently and as part of the research team
Strong knowledge of, and adherence to, regulatory requirements in conducting human subject research
Exceptional computer skills (word processing, databases, spreadsheets, email, internet, and spreadsheets) required.
Good command of English language, including medical and scientific terminology.
Exceptional organizational, documentation and communication skills and the flexibility to handle multiple tasks at once and adhere to deadlines.
Effective analytical skills.
Excellent communication skills (interpersonal, verbal, written)
Duties will be performed in ambulatory, clinical research and office settings.
Responsible for all sponsor billing requirements for applicable studies, processing subject payments
Responsible for prudent fiscal management of study and program resources (e.g. supplies, etc.).
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.