Clinical Research Coordinator I - Lombardi Comprehensive Cancer Center

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Requirements

Georgetown University’s Lombardi Comprehensive Cancer Center, 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.

The Clinical Research Coordinator I serves as clinical research coordinator for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center. They collaborate with Data Manager(s) to assure documentation for the clinical trial is complete and accurate, assisting with query resolution in a timely manner. Acting as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors, the incumbent has duties include, but are not limited to:

• Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle.

• Collaborate with investigators and more senior study team members by participating in recruitment and selection of study participants, documenting and collecting data to support protocol screening and determining compliance with eligibility requirements.

• Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines.

• Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines.

• Assist in the assessment, management, and coordination across the continuum of care (outpatient, inpatient, and home) including triage of phone calls, symptom management, and proactive patient communication.

• Coordinate the collection of research specimens per protocol requirements, providing patient education about clinical trial participation, treatment, potential side effects, and required testing.

• Schedule/conduct in-service training for appropriate staff on assigned clinical trials, regularly updating the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials.

• Document and report serious adverse events per protocol and institutional policy.

• Perform all duties in accordance with applicable laws and regulations. Adheres to Georgetown University Medical Center’s philosophies, policies, and SOPs, working in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.

Work Interactions

• Clinical Research Manager

• Disease Group members: Principal Investigators, Physicians, Clinicians

• Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians

• External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff

• Clinical trial sponsors, auditors, and study monitors

Minimum Requirements and Qualifications

• Bachelor’s Degree in a scientific or health related field

• Two (2) years of related experience in clinical research preferred

• Ability to work independently and function within a team

• Strong attention to detail

• Reliable and able to prioritize competing responsibilities

Work Mode Designation

This position has been designated as On-Campus. 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 website: