Georgetown University
Research Data Coordinator 2
Georgetown University, Washington, District of Columbia, us, 20022
Overview
Research Data Coordinator 2
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 academic programs, a global perspective, and opportunities to engage with Washington, D.C. Our community is driven by intellectual inquiry, a commitment to social justice, and making a difference in the world.
Responsibilities
Responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC).
Support all aspects of clinical research data management for trials 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.
Work on trials of varying complexity and disease indication.
Collaborate 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 to extract data for assigned research protocols including industry, national, and investigator-initiated studies.
Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to timelines and SOPs.
Ensure query resolution with proper physician and clinical study team oversight within time requirements.
Request and upload radiological images into sponsor-provided imaging platforms and resolve imaging-related queries with the study team.
Collect and organize source documents in electronic and paper format according to site policies.
Ensure accuracy of data in the Clinical Trials Management System (CTMS) and interface with study team to resolve discrepancies.
Schedule sponsor monitoring and study close-out visits.
Assist with monitoring and auditing preparation, including data deficiency corrections and corrective actions post-audit.
Communicate with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
Collaborate with physicians and Study Coordinators to maintain protocol integrity.
Assist with training of incoming Research Data Coordinators on electronic data capture systems and data entry.
Attend protocol-related training and complete required study training within the designated timeframe.
Prepare for and participate in site initiation visits.
Maintain compliance with departmental, institutional, and federal requirements and regulations; maintain controls to assure data accuracy, completeness, and confidentiality.
Maintain confidentiality standards for all potential and enrolled study participants; comply with HIPAA regulations.
Other duties as assigned.
Work Interactions This position performs duties in accordance with 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.
Requirements and Qualifications
High School Diploma or GED required.
Three (3) to five (5) years of related experience required.
Strong candidates exhibit: Ability to work independently and within a team; strong attention to detail; reliable and able to prioritize competing responsibilities.
Work Mode Designation Pay Range:
The projected salary or hourly pay range for this position is $18.28 - $27.33. Compensation is determined by qualifications, experience, education, skills, certifications, and university needs.
Current Georgetown Employees:
If you currently work at Georgetown University, please log in to GMS to view Jobs at Georgetown.
Submission Guidelines Please note that to be considered for any position at Georgetown University you must submit a resume for each position of interest. Documents are not kept on file for future positions.
Assistance If you are a qualified individual with a disability and need a reasonable accommodation, please click here or contact IDEAA at 202-687-4798 or ideaa@georgetown.edu. For application process assistance, call 202-687-2500. For more about Georgetown benefits, visit Georgetown Works.
EEO Statement Georgetown University is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other characteristic protected by law.
Benefits Georgetown University offers a comprehensive benefits package including medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts, and voluntary insurance options. Learn more on the HR website.
To apply , visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Building-D-3rd-Floor/Research-Data-Coordinator-2_JR23555-1
#J-18808-Ljbffr
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 academic programs, a global perspective, and opportunities to engage with Washington, D.C. Our community is driven by intellectual inquiry, a commitment to social justice, and making a difference in the world.
Responsibilities
Responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC).
Support all aspects of clinical research data management for trials 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.
Work on trials of varying complexity and disease indication.
Collaborate 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 to extract data for assigned research protocols including industry, national, and investigator-initiated studies.
Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to timelines and SOPs.
Ensure query resolution with proper physician and clinical study team oversight within time requirements.
Request and upload radiological images into sponsor-provided imaging platforms and resolve imaging-related queries with the study team.
Collect and organize source documents in electronic and paper format according to site policies.
Ensure accuracy of data in the Clinical Trials Management System (CTMS) and interface with study team to resolve discrepancies.
Schedule sponsor monitoring and study close-out visits.
Assist with monitoring and auditing preparation, including data deficiency corrections and corrective actions post-audit.
Communicate with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
Collaborate with physicians and Study Coordinators to maintain protocol integrity.
Assist with training of incoming Research Data Coordinators on electronic data capture systems and data entry.
Attend protocol-related training and complete required study training within the designated timeframe.
Prepare for and participate in site initiation visits.
Maintain compliance with departmental, institutional, and federal requirements and regulations; maintain controls to assure data accuracy, completeness, and confidentiality.
Maintain confidentiality standards for all potential and enrolled study participants; comply with HIPAA regulations.
Other duties as assigned.
Work Interactions This position performs duties in accordance with 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.
Requirements and Qualifications
High School Diploma or GED required.
Three (3) to five (5) years of related experience required.
Strong candidates exhibit: Ability to work independently and within a team; strong attention to detail; reliable and able to prioritize competing responsibilities.
Work Mode Designation Pay Range:
The projected salary or hourly pay range for this position is $18.28 - $27.33. Compensation is determined by qualifications, experience, education, skills, certifications, and university needs.
Current Georgetown Employees:
If you currently work at Georgetown University, please log in to GMS to view Jobs at Georgetown.
Submission Guidelines Please note that to be considered for any position at Georgetown University you must submit a resume for each position of interest. Documents are not kept on file for future positions.
Assistance If you are a qualified individual with a disability and need a reasonable accommodation, please click here or contact IDEAA at 202-687-4798 or ideaa@georgetown.edu. For application process assistance, call 202-687-2500. For more about Georgetown benefits, visit Georgetown Works.
EEO Statement Georgetown University is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, national origin, race, religion, sex, sexual orientation, veteran status, or any other characteristic protected by law.
Benefits Georgetown University offers a comprehensive benefits package including medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts, and voluntary insurance options. Learn more on the HR website.
To apply , visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Building-D-3rd-Floor/Research-Data-Coordinator-2_JR23555-1
#J-18808-Ljbffr