Data Manager II for Clinical Research Management Office, Lombardi Comprehensive Cancer Center Georgetown University Medical Center
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.RequirementsData Manager II for Clinical Research Management Office, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center
The Data Manager II
is responsible for data management for Phases I, II, and III of oncology clinical trials of varying complexity and disease indication. Reporting to the CRMO Administrative Director, the Data Manager II
has duties that include but are not limited to:
- Supports all aspects of clinical research data management for clinical trials conducted in the LCCC Clinical Research Management Office (CRMO), including collection of data from source documents and medical records and completion of case report forms per sponsor requirements.
- Works collaboratively with trial stakeholders and internal study teams (physicians, regulatory team members, study coordinators, nursing staff, research lab technicians, and research pharmacy team members).
- Reviews and analyzes information from medical records to extract data for all assigned research protocols - e.g., industry, national, and investigator-initiated studies.
- Accurately captures data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs).
- Ensures query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements.
- Requests and uploads radiological images into sponsor-provided imaging platforms according to each study protocol.
- Resolves imaging-related queries with the assistance of clinical study team.
- Collects and organizes source documents in electronic and paper format according to site policies.
- Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and keys dates; and interfaces with study team members to resolve any discrepancies.
- Schedules sponsor monitoring and study close-out visits.
- Provides support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.
- Communicates appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
- Collaborates closely with physicians and study coordinators to maintain protocol integrity.
- Assists with training of incoming data managers, including the use of electronic data capture systems, answering data entry questions, and monitoring data entry for new staff and new protocols.
- Attends protocol-related training and completes all required study training in the required timeframe.
- Prepares for, and participates in, site initiation visits.
- Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations.
- Maintains controls to assure accuracy, completeness, and confidentiality of research data.
- Maintains confidentiality standards for all potential and enrolled study participants; and complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
- Performs all duties in accordance with all applicable laws and regulations.
- Adheres to Georgetown University Medical Center's philosophies, policies, and SOPs.
- Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.
Work Mode: Hybrid 3 Days.
- High School diploma or equivalency
- 3 to 5 years of related experience
- Ability to work independently and function within a team
- Strong attention to detail
- Reliability and ability to prioritize competing responsibilities
Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff and AAP positions can be found on the Department of Human Resources Mode of Work Designation
.Current Georgetown Employees:
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Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.Need Assistance:
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for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected]
Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website
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 (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law
Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu
or view the online interactive benefits guide
for more information.
To apply, visit https://apptrkr.com/2695047
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