Data Manager I, Lombardi Clinical Research Management Office (CRMO) Georgetown University

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 I, Lombardi Clinical Research Management Office (CRMO) - Georgetown University

Georgetown Lombardi Comprehensive Cancer Center (LCCC) - 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 northern New Jersey.

The Data Manager I is responsible for data management for phases I, II, and III of oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC) in accordance with all applicable laws and regulations. They perform all duties in accordance with all applicable laws and regulations, adhere to Georgetown University Medical Center's philosophies, policies, and SOPs; and work in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice. Reporting to the CRMO Administrator, and interacting with Disease Group Members (Principal Investigators, Physicians, Clinicians), CRMO members, external clinicians and staff, and clinical trial sponsors, auditors, and study monitors, the Data Manager I has duties that include but are not limited to:

Data Management

• 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
• Interface with study team members to resolve discrepancies
• Collaborate closely with physicians and study coordinators to maintain protocol integrity
• 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

Trial Monitoring & Auditing

• Prepare for, and participate, in site initiation visits
• Schedule sponsor monitoring and study close-out visits
• Provide support during internal and external monitoring and auditing - e.g., sponsor, regulatory agencies - preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit
• Communicate appropriately with pharmaceutical sponsors, study monitors, and auditors

Departmental & Other Responsibilities

• Attend and participate in Data Management team meetings, staff meetings, and other departmental meetings and training
• Attend study meetings and provide updates on protocol activities
• Attend protocol-related training and complete all required study training in the required timeframe

Qualifications

• High School diploma or GED/equivalency
• Up to two (2) years of related experience
• Ability to work independently and function within a team
• Strong attention to detail, reliability, and prioritizing skills for completing demands

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 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.


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