Study Activation Coordinator, Lombardi Comprehensive Cancer Center – Georgetown University Medical Center

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Requirements

Study Activation Coordinator, 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.

Job Overview

The Study Activation Coordinator monitors the progress of clinical trials throughout the study activation process within the Lombardi Comprehensive Cancer Center’s Clinical Research Management Office (CRMO) in pursuit of efficient, competitive study activation timelines. They work with key stakeholders in a variety of departments and functional areas to identify barriers, develop solutions, and communicate progress.  Duties include but are not limited to:

• Facilitate the study activation process by serving as a liaison between Georgetown University departments, and LCCC CRMO functional units, including but not limited to the regulatory and finance teams, as well as various internal protocol review bodies.
• Manage clinical research activation timelines and activity by monitoring clinical research submissions, including to affiliate or network sites, to ensure efficiency and accuracy.
• Communicate study updates to appropriate stakeholders internally and externally as needed.
• Ensure accuracy of data in the Clinical Trial Management System (CTMS) and associated clinical trial monitoring systems.
• Conduct quality review and maintain inventory of study status throughout the study activation process.
• Implement quality measures in the CTMS to document and track pipeline trials.
• Compile activation metrics and reports for use by senior management and cancer center leadership.
• Work directly with key stakeholders and senior management to examine opportunities for decreasing study time to activation and promote the use of novel approaches across CRMO units to resolve issues and problems.
• Develop and lead educational effort at LCCC pertaining to time to study activation.
• May coordinate or assist in the issuance and maintenance of NCI National Clinical Trial Network membership and ensure appropriate user access to protocol information.
• Actively participate in meetings, task forces, and committees as assigned.

Work Interactions

• Regulatory Manager and Clinical Research Manager
• Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, and Laboratory Technicians
• Disease Group members: Principal Investigators, Physicians, and Clinicians
• External department personnel: Clinical Research Operations Office (CROO), Radiation Safety Committee, Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), nursing, pharmacy, radiology, pathology, and laboratory
• Clinical trial sponsors

Qualifications

• Bachelor’s degree in a scientific or health related field
• 3 to 5 years of related experience
• Strong candidates exhibit ● Knowledge of clinical research, research processes, and Good Clinical Practice (GCP) ● Excellent verbal and written communication skills ● Excellent organizational skills and attention to detail, and ● Reliability and ability to prioritize competing responsibilities

Preferred qualification

Strong working knowledge of FDA, NCI, OHRP, and ICH requirements

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

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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:

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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 .