Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Protocol Coordinator at the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers: - Competitive compensation and comprehensive benefit package
Optional health, vision, and dental plans
-Vacation leave as well as 10 paid federal holidays and 401K plan. - Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall:
Provide overall support for the administration, oversight and monitoring of clinical studies and clinical trials to Senior Leadership within DEM with the goal of ensuring compliance, safety and improving standardization of these tasks within the division.
Participate in meetings and provide minutes for the Clinical Science Working Group within the DDEMD.
Track medium- and high-risk investigator-initiated clinical trials by developing and maintaining files for bi-annual and annual risk assessments and flagging those which require increased oversight, including interim progress reports; produce and submit annual report for studies at high risk to Senior Leadership.
Establish procedures for tracking of recruitment and retention for clinical studies and clinical trials within the Division.
Establish and maintain computerized folders of clinical trials according to the format recommended by the Office of Clinical Research Support (OCRS).
Develop and maintain spreadsheets to track and analyze clinical study oversight processes.
Use Query/View/Reporting System (QVR), Research Portfolio Online Reporting Tools (RePORT), and other databases to compile reports and presentations to scientific and lay audiences.
Review protocols and adverse events for clinical studies and clinical trials.
Oversee activities related to the operation of Data and Safety Monitoring Board (DSMB), Observational Study Monitoring Board- (OSMB) and External Expert Panel (EEP) activities, including identifying and inviting potential members, identifying conflicts of interest and compiling the associated documentation, logistical support for the scheduling of meetings and calls, attending conference calls, taking minutes of calls and meetings, preparing the correspondence from program officials to the investigators and reviewing the investigators’ subsequent response prior to forwarding it to the DSMB/OSMB.
Act as a resource for Senior Leadership by developing expertise in Standard Operating Procedures (SOPs) for the oversight and monitoring of clinical trials and studies within DDEMD and provide expertise in approaches to improve recruitment and retention of study participants.
Act as a liaison between DDEMD program staff and the Data Coordinating Centers (DCCs) of clinical trials and studies supported by DDEMD to ensure timely response to action items identified after calls and meetings.
Act as a liaison between the DCC and the NIDDK repository ensuring timely deposition of samples and data according to current policies.
Participate in the development of budgets for new clinical trials and studies and track budgets through the course of the clinical trial.
REQUIREMENTS. The contractor must have:
Master’s degree in Public Health or Nursing or a Bachelor’s degree in Nursing with three (3) years of specialized experience equivalent to a Master’s degree. Specialized experience could include clinical program management or health related program management.
Minimum of two (2) years of practical experience in clinical trial or clinical study coordination, safety monitoring and oversight within the context of an academic or medical center.
Strong knowledge of good clinical practices, clinical site monitoring, compliance with regulatory requirements, reporting of adverse events, recruitment and retention of clinical populations.
Experience with writing of consent forms for Institutional Review Boards.
Experience in clinical and scientific terminology.
Excellent organizational, project management, analytical, and computer skills.
Minimum of intermediate level proficiency in use of MS Office Suite.
Minimum of intermediate level proficiency in the use of spreadsheets, databases and websites.
Knowledge of and experience using Pubmed.
Experience with NIH practices is considered a plus.
PLEASE APPLY ONLINE When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.
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