Cape Fox Shared Services
Clinical Protocol Coordinator
Cape Fox Shared Services, Rockville, Maryland, us, 20849
Concentric Methods is seeking a Clinical Protocol Coordinator to join our team in Bethesda, MD in support of the NIH.
Responsibilities:
Assist researchers with protocol development, assembly and review of clinical trial documents.Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.Assist researchers to develop initial and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.Assist researchers develop and maintain trial related documents and operational procedures.Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.Maintain study databases and conduct basic analysis.Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.Assist researchers prepare, review and submit clinical data to monitoring agencies.Assist researchers collect, distribute and file regulatory documents.Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.Assist researchers prepare submissions to regulatory bodies in support of clinical trials.Provide technical support to researchers and the clinic.Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.Prepare draft documents for senior staff review.Coordinate with other offices such as the Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new revised documents with policies.Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
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Responsibilities:
Assist researchers with protocol development, assembly and review of clinical trial documents.Assist researchers develop, prepare internal research proposals, abstract submissions, poster presentations and manuscript drafts.Assist researchers develop protocol documentation including schemas, patient calendars and teaching aids.Assist researchers develop clinical research informed consent and other ethics and regulatory related documentation.Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.Assist researchers to develop initial and amended clinical research protocols and related documentation throughout the lifecycle of the study, with special attention to the accuracy, consistency, and completeness of documents.Assist researchers develop and maintain trial related documents and operational procedures.Assist researchers collect, organize and maintain all study documentation to include investigator qualifications, trial logs, and safety reports.Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.Assist researchers write and edit study protocols, and prepare amendments, reviews, reports, and other necessary forms.Assist researchers prepare and submit study safety reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.Assist researchers track and review adverse event files and report events in accordance with Institutional Review Board (IRB) processes and policies.Maintain study databases and conduct basic analysis.Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.Assist researchers prepare, review and submit clinical data to monitoring agencies.Assist researchers collect, distribute and file regulatory documents.Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.Organize quality assurance activities with pertinent regulatory bodies such as FDA, NIH, pharmaceuticals and others.Assist researchers prepare and communicate with IRB and NIH Clinical Center for protocol approval.Assist researchers prepare submissions to regulatory bodies in support of clinical trials.Provide technical support to researchers and the clinic.Work with the NINDS Clinical Trials Unit CTU and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.Prepare draft documents for senior staff review.Coordinate with other offices such as the Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication to integrate and ensure consistency of new revised documents with policies.Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities.Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
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