Clinical Research Coordinator 1

Georgetown University•Vinalhaven, ME

2d•$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 Lombardi Comprehensive Cancer Center. 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 regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice. Incumbent 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; document and collect data to support protocol screening and determine 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 collection of research specimens per protocol requirements. Provide 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 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. Document and report serious adverse events per protocol and institutional policy. Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors. Other duties as assigned

Requirements

Bachelor’s Degree in a scientific or health related field required.
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.

Responsibilities

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; document and collect data to support protocol screening and determine 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 collection of research specimens per protocol requirements.
Provide 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 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.
Document and report serious adverse events per protocol and institutional policy.
Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors.
Other duties as assigned