Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Study Activation Coordinator for Clinical Research Management Office, Lombardi Comprehensive Cancer Center Georgetown University Medical Center (GUMC)
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Study Activation Coordinator for Clinical Research Management Office, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center (GUMC)
Georgetown'sLombardi Comprehensive Cancer Center (LCCC) committed to recruiting, educating, and developing the careers of the next generation of outstanding basic and clinical cancer researchers who will continue the fight against cancer.
The Study Activation Coordinator monitors the progress of clinical trials throughout the study activation process within the LCCC's CRMO) in pursuit of efficient, competitive study activation timelines; and works with key stakeholders in a variety of departments and functional areas to identify barriers, develop solutions, and communicate progress.
Reporting to the Regulatory Manager, the Study Activation Coordinator has primary duties that include but are not limited to:
Facilitate the study activation process as by serving as a liaison between Georgetown University departments and LCCC CRMO functional unit, including for example, the regulatory and finance teams, and various internal protocol review bodies
Manage clinical research activation timelines and activity by monitoring clinical research submissions - including affiliate or network sites - to ensure efficiency and accuracy
Communicate study updates to appropriate stakeholders internally and externally as needed.
Ensure accuracy of data in the Clinical Trial Management System (CTMS) and associated clinical trial monitoring systems
Conduct quality review and maintain inventory of study status throughout the study activation process
Implement quality measures in the CTMS to document and track pipeline trials
Compile activation metrics and reports for use by senior management and cancer center leadership
Work directly with key stakeholders and senior management to examine opportunities for decreasing study time to activation and promote the use of novel approaches across CRMO units to resolve issues and problems
Develop and lead LCCC's educational effort regarding time to study activation.
As needed, coordinate or assist in the issuance and maintenance of NCI National Clinical Trial Network membership and ensure appropriate user access to protocol information
Actively participate in meetings, task forces, and committees as assigned
Bachelor's degree in a scientific or health related field
3 to 5 years of related experience
Knowledge of clinical research, research processes, and Good Clinical Practice (GCP)
Excellent verbal and written communication skills
Excellent organizational skills and attention to detail
Reliability and skilled in prioritizing competing responsibilities
Strong working knowledge of FDA, NCI, OHRP, and ICH requirements
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