Clinical Research Coordinator II
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POST DATE 8/23/2016
END DATE 11/22/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONAPPLY GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Clinical Research Coordinator II is responsible for coordinating the research activities at the Harvard site for a multicenter NIH funded head injury study, TRACK TBI, Transforming Research and Acquiring Clinical Knowledge in Traumatic Brain Injury. With the Principal Investigator, the Clinical Research Coordinator II (CRCII) will work independently and will be responsible and accountable for playing a major role in assisting in the implementation of research protocols using scientific methods, including working with physicians, clinical nurses and patients to identify and recruit eligible patients, obtaining all necessary approvals and informed consent forms, screening and enrolling patients into the study, ensuring blood is collected on time, and coordinating MRI and follow-up visits in light of ethical considerations, and acting as a liaison between the patient and other members of the team regarding the research protocol. The CRCII is responsible for database development and data entry of patient data for the study. The CRCII works closely with personnel at the San Francisco site, ensuring that blood specimens are handled and received appropriately and MRI studies are performed in accordance with study protocols. He/she organizes visits and patient family interviews for participating physicians, nurse practitioners, and nurses. He/she logs in all applicable data elements as requested and coordinates information and supply transfer as necessary to complete study elements at multiple sites. He/she summarizes data and information for review and analysis by the investigators and project team, participates in regular lab meetings, and has the opportunity to assist with data analysis and production of presentations and manuscripts.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
* Coordinates and implements research study according to the study protocol. Demonstrates understanding and knowledge of designated study protocols and methods of implementation.
* Organizes, establishes and maintains the research database and uses the database to extract information for reports, papers and feedback to the study team.
* Administers questionnaires and outcomes tests and records data for study subjects in the pediatric age range.
* Works with physicians, clinical nurses and patients to identify and screen appropriate candidates for protocols and evaluates criteria for inclusion/exclusion per study protocol. Obtains and files all necessary approvals, patient written informed consent, and demographic information required for patient enrollment.
* Screening patients may require working some evenings and some weekends when the patient population that can be screened for enrollment is greatest.
* Collects, compiles, tabulates and analyzes research data. Ensures that data is entered into the database accurately and in a timely fashion. Reviews and analyzes significant data and statistics in the computer file. Works to ensure that appropriate control systems are in place to monitor the progress of data acquisition and to define new approaches to data management. Periodically assesses quality and completeness of database and patients' files. Maintains all required records including documentation of all consents, and information needed for the Institutional Review Board, granting agencies, and other regulatory and/or funding bodies. Serves as a resource in providing statistical information from the database.
* Has the opportunity to assist in writing research publications, performs independent literature searches, analyze data, prepare graphs, and assist in presenting study findings to interested groups both inside and outside of the hospital.
* Performs administrative duties such as quality assurance, documentation for Human Studies approval, and study progress reports.
* Contacts patients and/or families via in person, written and telephone communications for the purpose of explaining the nature of the study and setting up visits and interviews. Arranges and coordinates scheduling of initial assessment and subsequent assessments as outlined in study protocol.
* Schedules MRI scans for human subjects at the appropriate times according to the protocol. Ensures that MRI studies are performed appropriately in accordance with the TRACK-TBI radiology core protocols.
* Schedules blood sample collection at the appropriate times according to the protocol and sets up blood draw kits. Collects blood, processes and stores blood collections according to the protocol. Works closely with the San Francisco site ensuring that blood specimens are handled and received per protocol by San Francisco site.
* Collects, analyzes and assures the quality of pertinent patient documentation according to established guidelines. Maintains confidential patient files including all correspondence, information, raw data and follow-up status of all study patients. 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 patients in the study, discussing problems and exchanging information with clinical nurses and other care providers and study personnel.
* Assesses learning needs and educates patients and family as appropriate regarding protocol management and participation in research project.
* Organizes project team meetings and prepares the agenda under direction of the principle investigator.
* Assesses patient participation on a continuous basis in light of ethical considerations. Acts as liaison between patient and other members of the team regarding the research protocol.
* Responsible for developing and maintaining a web page for study information in conjunction with the Principle Investigator, Administrative Director, Marketing and the Research Management Office.
* Designing/implementing advertisements when appropriate for research study recruitment.
* Establishes effective working relationships with the project team.
* Oversees the post-award review of government grants to assure institutional and sponsor compliance and budgetary appropriateness. Reconciles and analyzes monthly financial statements. Maintains communication channels with hospital grant department administrators and addresses any administrative or compliance issues in a timely manner.
* Bachelors degree required in a science or healthcare related field, Masters preferred
* Minimum of 1-2 years of related experience required
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
* Exceptional computer skills (including operating systems, word processing, database, electronic mail, internet, and spreadsheets) required.
* Good command of English language, including medical and scientific terminology.
* Exceptional organizational skills and the flexibility to handle multiple tasks and deadline pressures.
* Effective analytical skills and ability to resolve technical problems
* Excellent interpersonal/ communication skills.
* Duties will be performed in a hospital inpatient, clinic, laboratory, and office setting.
* None. May share in the supervision of undergraduate or graduate student volunteers, mostly for data entry and data checking.
* No direct fiscal responsibilities, however, is responsible for prudent fiscal management of program resources (e.g. supplies, etc.). Reviews study funds each month to assess proper reimbursement for submitted paperwork. Works with senior grant administrator for specific budget issues.
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