Clinical Research Coordinator I

Clinical Research Coordinator

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Serves as clinical research coordinator for phase I, II, and III oncology clinical trials conducted in the Clinical Research Management Office (CRMO) of Lombardi Comprehensive Cancer Center.

Incumbent duties include, but are not limited to:

• Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle.
• Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines for minimal risk studies.
• Schedule and coordinate study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines.
• Assist with triaging phone calls and proactive patient communication.
• Coordinate collection of research specimens per protocol requirements.
• Schedule in-service training for appropriate staff on assigned clinical trials.
• Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials.
• Collaborate with Data Manager(s) to assure documentation for the clinical trial is complete and accurate; assist with query resolution in a timely manner.
• Schedule/facilitate sponsor meetings including PSV, SIV, MV
• Document and report serious adverse events per protocol and institutional policy, with input from PI or senior member of clinical research team.
• Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors.
• Other duties as assigned.

Performs all duties in accordance with applicable laws and regulations. Adheres to Georgetown University Medical Center's philosophies, policies, and SOPs. Works in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

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

Requirements and Qualifications

• Bachelor's Degree in a scientific or health related field required.
• Three (3) to five (5) years of related experience in clinical research preferred.
• Strong candidates exhibit:
• 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. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website.

$61,000 ($29.33/hr) range $47,586 - $104,689 USD Annual

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$20.16 - $31.30

Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

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.

GU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.