Clinical Research Coordinator 2

Job Overview

Serves as Clinical Research Coordinator 2 for the Cellular Therapy clinical trials conducted through the Lombardi Clinical Trials Office (Lombardi CTO) of the Lombardi Comprehensive Cancer Center at Georgetown University.

Additional duties include, but are not limited to:

• Serving as Cellular Therapy champion
• Liaise with Lombardi CTO, MedStar Health, and GUMC Departments, regarding the status of studies in the start-up process to support timely activation of new Cellular Therapy trials and provide regular updates for activated trials
• Establish and maintain regular meeting cadence for Cellular Therapy clinical trials
• Collaborate with Cellular Therapy Co-Leads to create, establish, and distribute meeting agendas and document/distribute minutes and actions items from each meeting
• Schedule in-service training for appropriate staff assigned on clinical trials

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.
• Schedule and coordinate study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines.
• Coordinate collection of research specimens per protocol requirements
• 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 Coordinators(s) to ensure documentation for the clinical trial is complete and accurate in compliance with protocol and sponsor requirements; 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
• Conduct follow-up with study participants in accordance with established standards and protocols.
• Act as a liaison with sponsors during study start-up activities and participate in site initiation visits, monitoring visits, and audits.
• Identify potential barriers to patient and physician participation in clinical trials; develop and implement methods to alleviate those barriers.
• Actively participate in meetings and committees, as assigned.
• Other duties as assigned.

The Clinical Research Coordinator 2 is expected to perform all duties in accordance with applicable laws and regulations and adhere to Georgetown University Medical Center s philosophies, policies, and SOPs, as well as work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.