Data Coordinator 1, Clinical Research Management Office Georgetown University Medical Center

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Requirements

Data Coordinator 1, Clinical Research Management Office - 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 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:

• 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
• Supports trials of varying complexity and disease indication
• Works collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team)
• Reviews and analyzes 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 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 key dates
• Interfaces with study team members to resolve 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
• 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 Interactions

• 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

Qualifications

• High School diploma or equivalency
• Up to two (2) years of related experience
• Ability to work both independently and as a team member
• Strong attention to detail
• Reliability
• Ability to prioritize competing responsibilities

Work Mode: 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 positions can be found on the Department of Human Resources Mode of Work Designation.

Current Georgetown Employees:

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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 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 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.

COVID-19 Vaccination Requirements:

The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Data-Coordinator-1--Clinical-Research-Management-Office---Georgetown-University-Medical-Center_JR14592







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