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Research Data Coordinator 1 - Lombardi Comprehensive Cancer Center - Georgetown University Medical C
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Request and upload radiological images into sponsor-provided imaging platforms according to each study protocol. Collaborate closely with physicians and Study Coordinators to maintain protocol integrity.
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Serves as protocol liaison to community-based physicians regarding patient referrals for clinical trials in coordination with the ACTU Study Coordinator. Acts as data manager for protocol and prepares new clinical protocol for IRB submission; coordinates and maintains activities to ensure study protocols are carried out effectively and appropriate time frame.
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Interface with representatives from key functional groups including Executive Management, Product Development/R&D, Regulatory Affairs, Quality Assurance, and Operations as well as Clinical Research Organizations (CROs) to set operational direction and strategy for clinical study activities.
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Completes and oversees analysis of protocol documents to generate study database design specifications including CRF/eCRF design, visit schedule, edit checks, system notifications, query logic, user role setup, randomization triggers, supply triggers, and medical coding.
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Performs research procedures, as needed per protocol, including screening and enrollment of research subjects, specimen/data collection, study baseline and follow-up visits under the direction of the PM/CRC/CRN.Other duties as assigned.
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Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings and participates in data collection of all subjects.
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13) Schedule participant screening visits in the VRC scheduling database; collect and enter initial pre-screening health and demographic information in database by interviewing subjects to determine protocol eligibility (14) Assist with and participate in community engagement (in a variety of settings including college campuses, community events, and community-based organizations) and study recruitment plans/strategies, to include marketing, community outreach, health education, etc.
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Work products and documents related to performing phlebotomy and other procedures; collect specimens from study participants; generate numeric tracking labels for samples prior to submitting samples; ensure that sample volumes collected are within protocol rules and NIH policies; oversee Phlebotomy Lab and ensure GCP and NIH CC guidelines are followed.
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Assists in the preparation and submission of regulatory documents to the study sponsor and IRB, as required by the protocol and regulatory requirements. Assist in the conduct and documentation of study visits and protocol-specific testing/interviews according to the study protocol.
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Evaluate annual IND annual reports for medical safety and report findings to RAB. Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to DAIDS' leadership to ensure trials are conducted according to protocol.
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The CRN operates as part of a team of both nursing staff and research assistants who assist the study coordinator and Investigator in protocol implementation. They assure a smooth implementation of the protocol on the CRU - and that the investigator's research study is implemented according to protocol; and provides - as needed - education to other staff members at the CRU or collaborating institutions, regarding protocols for which she is the provides primary care; and standard of care to non-research patients.
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Coordinates protocol-specific training to study site staff and investigators. Responsible for assisting with protocols from sponsors (federal and non-federal) and completing actions for the protocol to receive final IRB Approval.
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The Budget Analyst Associate will have overall responsibility for creation of study budgets based on detailed knowledge of the study protocol requirements, additional guidance from the sponsor, and input from assigned key staff.
$57,000 - $65,000 a yearFull-timeRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Acts as liaison and information resource about protocol for hospital departments, sponsors and other study centers. Anticipates the effect of the study on unit functioning; obtains prior approval from Nurse Manager for changes that adversely affect unit function.
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Planning Study start-up, anticipate implementation of protocol amendments, resulting in shifts in study timelines, recruitment and retention challenges, data management and vendor related issues.
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protocol study jobs in Washington, DC
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