Research Data Coordinator 1 - Lombardi Comprehensive Cancer Center

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Georgetown University's Lombardi Comprehensive Cancer Center, 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.' Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and Hackensack Meridian Health in northern New Jersey.

The Research Data Coordinator 1 position is responsible for data management for phase I, II, and III oncology clinical trials conducted within the Lombardi Comprehensive Cancer Center Clinical Trials Office (CTO) of the Lombardi Comprehensive Cancer Center (LCCC). They supports all aspects of clinical research data management for clinical trials conducted in the Lombardi CTO, including collection of data from source documents and medical records and completion of case report forms per sponsor requirements, supporting trials of varying complexity and disease indication. They work collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team),accurately capturing data in electronic or paper Case Report Forms (eCRFs/CRFs) and adhering to contractual timelines and site Standard Operating Procedures (SOPs). The incumbent 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.

Additional duties include, but are not limited to:

• 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, resolving imaging-related queries with the assistance of the clinical study team.
  
• Ensure query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements, requesting and uploading radiological images into sponsor-provided imaging platforms according to each study protocol.
  
• Collect and organize source documents in electronic and paper format according to site policies, ensuring 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, scheduling sponsor monitoring and study close-out visits.
  
• Collaborates closely with physicians and Study Coordinators to maintain protocol integrity, attending protocol-related training and completing all required study training in the required timeframe.
  
• Prepare for - and participate in - site initiation visits, assuring ongoing compliance with all departmental, institutional, and federal requirements and regulations.
  
• Maintain controls to assure accuracy, completeness, and confidentiality of research data, as well as confidentiality standards for all potential and enrolled study participants, complying with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
  
• Perform all duties in accordance with all applicable laws and regulations, adhering to Georgetown University Medical Center's philosophies, policies, and SOPs.
  
• Work 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
  
• Lombardi CTO 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
  

Requirements and Qualifications

• High School Diploma or GED
  
• Up to two (2) years of related experience
  
• Ability to work independently and function within a team
  
• Strong attention to detail
  
• Reliable and able to prioritize competing responsibilities
  

Work Mode Designation

This position has been designated as 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 positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:
$17.92 - $26.80

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

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 resume for each position of interest for which you believe you are qualified. 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:

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, 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.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Research-Data-Coordinator-1----Lombardi-Comprehensive-Cancer-Center_JR21735









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