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
Data Manager I, Clinical Research Team, Lombardi Comprehensive Cancer Center - G eorgetown University Medical Center
Georgetown Lombardi Comprehensive Cancer Center (LCCC) , part of Georgetown University Medical Center, seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of cura personalis, "care for the whole person."
The Data Manager I manages the data from numerous clinical trials and ensures the seamless transmission of data between clinical site and trial sponsor. Reporting to the Clinical Director, the
Data Manager I has responsibilities that include but are not limited to:
Manage trials of varying complexity and stages of the clinical trial lifecycle
Work collaboratively with trial stakeholders and internal study teams (Physicians, Regulatory Coordinators, Study Coordinators & Nursing staff, Research Laboratory Technicians, and Research Pharmacy team)
Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs)
Ensure query resolution with proper physician and clinical study team oversight within site-specific time requirements
Upload radiological images into sponsor-provided imaging platforms according to each study protocol
Resolve imaging-related queries with the assistance of clinical study team
Collect and organize source documents in electronic and paper format according to site policies
Schedule sponsor monitoring and study close-out visits
Participate in data preparation for audits and QA review
Communicate appropriately with pharmaceutical sponsors, auditors, study monitors, physicians, and study coordinators
Collaborate closely with physicians and study coordinators to maintain protocol integrity
Assist with training of incoming DMs in data capture, query resolution, and protocol compliance
Participate in disease team meetings, site initiation visits, audit meetings, and other study related meetings
Perform all duties in accordance with all applicable laws and regulations
Adhere to Georgetown University Medical Center's philosophies, policies, and SOPs
Work in compliance with Human Subject Protection regulations, patient confidentiality and HIPAA requirements, and Good Clinical Practice.
Qualifications
Bachelor's degree in a science-related field
2 years of related experience in clinical research
Ability to work independently and function within a team
Reliability
Strong prioritization skills
Preferred qualifications
Advanced degree in a science-related field
1 year of related experience in clinical research
Current Georgetown Employees:
If you currently work at Georgetown University, please exit this website and login to GMS ( gms.georgetown.edu ) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.
Submission Guidelines:
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:
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. 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 .
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 (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law .
Benefits:
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.