Clinical Research Coordinator I

Summary

Georgetown University is an academic institution with a comprehensive cancer center conducting oncology clinical research. The Clinical Research Coordinator I coordinates phase I, II, and III oncology clinical trials throughout their lifecycle, including participant communication, study procedures, regulatory documentation, specimen collection, and collaboration with research teams and sponsors.

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

Skills

• Bachelor's Degree in a scientific or health related field required
• Ability to work independently and function within a team
• Strong attention to detail
• Reliable and able to prioritize competing responsibilities
• Three (3) to five (5) years of related experience in clinical research preferred

Qualifications

Must Haves

• Bachelor's Degree in a scientific or health related field required
• Ability to work independently and function within a team
• Strong attention to detail
• Reliable and able to prioritize competing responsibilities

Nice to Haves

• Three (3) to five (5) years of related experience in clinical research preferred

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Retirement savings
• Tuition assistance
• Work-life balance benefits
• Employee discounts
• An array of voluntary insurance options