- Support 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
- Administer 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; and as necessary, 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; and comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations
- Clinical Research Manager
- Disease Group members: Principal Investigators, Physicians, Clinicians
- Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians
- External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff
- Clinical trial sponsors, auditors, and study monitors
- 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 Reliability and ability to prioritize competing responsibilities
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Research Data Coordinator I - Washington, United States - Georgetown University
Description
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.
RequirementsResearch Data Coordinator I - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center
Georgetown's Lombardi Comprehensive Cancer Center (LCCC) 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 others.
The Research Data Coordinator I is responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center in duties that include but are not limited to:
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
Current Georgetown Employees:
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Submission Guidelines:
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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.
