LCCC Consortium IIT Office Coordinator

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

LCCC Consortium IIT Office Coordinator, Lombardi Comprehensive Cancer Center – Georgetown University Medical Center

Georgetown Lombardi Comprehensive Cancer Center – Washington’s only National Cancer Institute-designated Comprehensive Cancer Center – serves as the research engine for MedStar Health, Georgetown University’s clinical partner. Georgetown Lombardi is also an NCI-recognized research consortium with Hackensack Meridian John Theurer Cancer Center in Bergen County, New Jersey.

Job Overview

The LCCC Consortium IIT Office Coordinator supports the administration and progress of single and multi-site ITTs, which have originated within LCCC, and for which the institution or the Principal Investigator serves as the Study Sponsor.  The Consortium ITT Office supports all operational aspects of single- and multi-site IITs regardless of Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.

They monitor the timelines/milestones of the assigned clinical studies and develop strategies for staying on track, and for ensuring that study personnel at all study sites conduct the applicable studies according to the clinical protocol, current Good Clinical Practices governing clinical research, and all applicable regulatory requirements; and for ensuring that study payments to participating sites are issued as per study agreements.

Work Interactions

The ITT Office Coordinator interacts effectively with a wide variety of individuals including:

• LCCC Consortium IIT Office Program Manager, Local IIT Office Project Manager, other IIT Office staff
• CRMO Administrative Director, Medical Director, and Manager Team
• Investigators, faculty and staff from peer Academic Medical Centers
• Faculty and staff at LCCC consortium sites
• CRMO Clinical Operations Team, Data Team, and Regulatory Team
• Sponsors, foundations, and other protocol funding entities

Qualifications  

• Bachelor’s degree – preference for Master’s level degree
• At least 3 years of clinical trials experience, which must include a minimum of 1 year of clinical operations experience
• Willingness and availability to perform light travel

Knowledge, skills, and abilities

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements – i.e. , Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Strong communication and interpersonal skills, including proficient use of the English language
• Ability to interact effectively with a wide variety of individuals
• Strong organizational and problem-solving skills
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics
• Good team leadership skills
• Effective mentoring and training skills
• Excellent customer service skills
• Good judgement
• Effective presentation skills
• Ability to manage competing priorities
• Strong software and computer skills, including MS Office applications
• Ability to establish and maintain effective working relationships with coworkers, manager, and clients

Preferred qualifications  

• Degree in biological, health sciences, or related field
• Oncology clinical research experience
• SOCRA or ACRP certification

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

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Submission Guidelines:

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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 .