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Research Data Coordinator 1

3 months ago

Washington, Washington, D.C., United States Georgetown University 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

Research Data Coordinator - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center


Georgetown's Clinical Research Management Office (CRMO) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators.

This includes all regulatory documents, IRB 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.

Job Overview


The Research Data Coordinator 1 is responsible for data management for phase I, II, and III oncology clinical trials conducted within the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC).


Duties include but are not limited to:

  • Support all aspects of clinical research data management for clinical trials conducted in the LCCC CRMO, including collection of data from source documents and medical records and completion of case report forms per sponsor requirements.
  • Support trials of varying complexity and disease indication
  • Work collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team)
  • Review and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including, but not limited to, industry, national, and investigator-initiated studies
  • 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- and sponsor-specific time requirements
  • Request and 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
  • Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates. Interface with study team members to resolve discrepancies
  • Schedule sponsor monitoring and study close-out visits
  • Provide support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit
  • Communicate appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members
  • Collaborate closely with physicians and Study Coordinators to maintain protocol integrity
  • Attend protocol-related training and complete all required study training in the required timeframe
  • Prepare for and participate in site initiation visits
  • Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations and maintain controls to assure accuracy, completeness, and confidentiality of research data
  • Maintain confidentiality standards for all potential and enrolled study participants; comply 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 Interactions and Work Mode Designation

  • Clinical Research Manager
  • Disease Group members: Principal Investigators, Physicians, Clinicians
  • Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians
  • External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
  • Clinical trial sponsors, auditors, and study monitors
This position has been designated as Hybrid. 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 website:

Requirements and Qualifications

  • High School diploma or certified equivalency
  • Up to 2 years of related experience
  • Strong candidates exhibit:
  • Ability to work independently and function within a team
  • Strong attention to detail, and
● Reliability and ability to prioritize competing responsibilities
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Submission Guidelines:


Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified.

Documents are not kept on file for future positions.

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Need some assistance with the application process? Please call 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 comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options.

You can learn more about benefits and eligibility on the Department of Human Resources website.