Clinical Research Coordinator I

Georgetown University

26d•$47,586 - $104,689•Onsite

About The Position

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. The 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.

Requirements

Bachelor’s Degree in a scientific or health related field required.
Three (3) to five (5) 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.

Responsibilities

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.