This job has expired

Data Manager 1 for Clinical Research Management Office, Lombard Comprehensive Cancer Center

Employer
Georgetown University
Location
Washington D.C.

View more

You need to sign in or create an account to save a job.


Data Manager 1 for Clinical Research Management Office, Lombard 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.

Requirements

Data Manager 1 for Clinical Research Management Office, Lombard Comprehensive Cancer Center - Georgetown University Medical Center

Job Overview

The Data Manager I (DM I) is responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC) in 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.
  • Administers 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. 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

Reporting to the Clinical Research Manager, the DMI interacts with
  • Disease Group members (Principal Investigators, Physicians, Clinicians)
  • Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technician
  • External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
  • Clinical trial sponsors, auditors, and study monitors


Qualifications
  • High School diploma or equivalency
  • Up to 2 of years of related experience
  • Ability to work independently and function within a team
  • Strong attention to detail
  • Reliability
  • Ability to prioritize competing responsibilities


Work Mode: Hybrid 3 Days. 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:

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 [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.

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.


To apply, visit https://apptrkr.com/2710452





Copyright ©2021 Jobelephant.com Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency

jeid-fcd9304637ba5d498c6011cc3b518519
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert