Data Manager II - Georgetown University Medical Center

Location
Washington D.C
Posted
May 10, 2019
Closes
Jun 16, 2019
Ref
JR06579
Industry
Education
Hours
Full Time
Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

As one of approximately 140 academic health and science centers in the United States, Georgetown University Medical Center seeks to provide, in a synergistic fashion, excellence in education - training physicians, nurses and other health care professionals, as well as biomedical scientists - and cutting-edge interdisciplinary research collaboration , enhancing our basic science and translational biomedical research capacity in order to improve human health.

The Data Manager II (DMII)position is vital to the research process. S/he is responsible for managing the data of numerous clinical trials, ensuring that the data collection is clear, accurate, and secure. At the discretion of management, the Data Manager II has additional duties that include but are not limited to:
  • Handles multiple trials at various stages of the research process, with the majority of the trials being very complex in nature and requiring experienced research personnel.
  • Acts as the point person for the most complex trials, working directly with the clinical study team, regulatory team, research laboratory techs, nursing staff, and all clinical trial representatives.
  • Accurately captures data in the appropriate format in electronic or paper Case Report Forms (eCRF/CRFs), adhering to multiple time demands and ensuring query resolution in a timely manner.
  • Collects and organizes source documents in patient paper charts for sponsor, institutional, and cooperative studies.
  • Prepares for and schedules monitor visits, audits, and QA review.
  • Interacts with pharmaceutical sponsors, auditors, study monitors, physicians, and study coordinators as necessary.
  • Collaborates closely with study coordinators to maintain protocol integrity, working directly with imaging technician and sponsors to ensure radiology images are uploaded to imaging platform according to protocol and resolving the queries specific to imaging.
  • Handles the training and mentoring for all DMI and fellow DMIIs in data capture, query resolution, and protocol compliance.
  • Performs all duties in accordance with all applicable laws and regulations, adhering to Georgetown University Medical Center's philosophies, policies, and SOPs.
  • Works in compliance with Human Subject Protection, patient confidentiality HIPAA and GCP.


Qualifications
  • Bachelor's Degree in Biology or Science related field
  • 2 year of related experience in clinical research or advanced degree in Biology or Science related field

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