Quality Control Coordinator - Lombardi Comprehensive Cancer Center

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Requirements

Georgetown University’s 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 Hackensack Meridian Health in northern New Jersey.

Reporting to the Lombardi Clinical Trials Office (Lombardi CTO) Training, Education, and Quality Control Manager, the Quality Control Coordinator I will interface with various faculty and staff in the development and maintenance of a cancer clinical research quality control program. This position will interface most closely with LCCC consortium clinical research staff and faculty in addition to the leadership and staff within Georgetown University Medical Center (GUMC) Office of Research Quality Assurance. Additional duties include, but are not limited to:

• Perform various study and staff level assessments to ensure adherence to Lombardi CTO and Georgetown University Medical Center (GUMC) Standard Operating Procedures (SOPs) and continued adherence to federal, state and other regulatory standards, requirements and guidelines.

• Through compliance activities, assist with assessing staff competency, evaluating protocol compliance and promoting successful internal and external audits of LCCC cancer clinical research studies.

• Work closely with the Lombardi CTO Administrative Director and Management Team as well as their Team Members (Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians, IIT Coordinators) to complete duties as assigned.

Work Interactions

The Quality Control Coordinator I works very closely with the Georgetown Office of Research Quality Assurance team members, LCCC Consortium Quality Control Team Members, and Disease Group Members (Principal Investigators, Physicians, Clinicians). S/he interacts with external department clinicians and staff (Infusion Nurses, Oncology Pharmacists, hospital staff), along with clinical trial sponsors, auditors, and study monitors.
 

Requirements and Qualitifications

• Bachelor’s Degree with the ability to perform light travel

• Up to two (2) years of oncology clinical trials experience and Knowledge and/or experience with NCI CCSG expectations preferred

• Working knowledge of regulations governing clinical research conduct and skill in applying, applicable clinical research regulatory requirements (iGood Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines)

• Strong understanding of medical and research terminology and experience working in oncology therapeutic research

• Strong leadership, mentoring, and training skills, as well as strong organizational and problem-solving skills

• Strong communication and interpersonal skills, including proficient use of the English language

• Effective presentation skills with the ability to effectively manage competing priorities and deliver high-quality results within defined timelines

• Proficient with technology applications including MS Office

• Ability to establish and maintain effective working relationships with supervisors, peers, and customers of the unit

• SOCRA or ACRP certification preferred

Work Mode Designation

This position has been designated as 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 website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range: