Data Manager, Clinical Research Management Organization - Georgetown University Medical Center

Location
Washington D.C.
Posted
Mar 27, 2017
Closes
May 05, 2017
Industry
Education, Research
Hours
Full Time
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Requirements

Data Manager, Clinical Research Management Organization - Georgetown University Medical Center

Georgetown University Clinical Research Management Office (CRMO), a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC), provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, Institutional Review Board submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on the Lombardi website, and design of electronic case report forms for institutional trials.

The Data Manager has the responsibility of managing the data of clinical trials and ensures that data collection is accurate.  Reporting to the Manager of Data Management, the Data Manager has duties include but are not limited to:

  • Collects and organizes research data in paper charts for sponsors, institutional and cooperative studies.
  • Accurately captures data in appropriate format in electronic or paper Case Report Forms (CRFs) within the expected time frame.
  • Ensures query resolution and/or data clarifications forms in a timely manner.
  • Requests radiology images and uploads the images into the imaging platforms.
  • Schedules the monitor visits and audits and organizes the data in preparation for monitor visits and audits.
  • Participates in site initiation visits.
  • Interacts with Pharmaceutical sponsors, Auditors, Study Monitor, Physicians and Study Coordinators.
  • Collaborates closely with study coordinators to maintain protocol integrity in preparation for sponsor or FDA Audits.
  • Provides support to study coordinators and lab technician in preparation of research kits.
  • Provides support to study coordinators on requesting and submitting pathology
  • Performs all duties in accordance with all applicable laws and regulations and Georgetown University medical Center's philosophy, policies, procedures and standards, and Human Subject Protection compliance adhering to patient confidentiality.

Requirements

  • Bachelor's Degree in Biology or Science related field and at least 1 year of related experience in clinical research, or
  • Master's degree in Biology or Science related field

Submission Guidelines:

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Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.

Need some assistance with the application process? Please call 202-687-2500

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability status, protected veteran status, or any other characteristic protected by law.