Clinical Research Coordinator 1

Georgetown University; United States; On-site; USD 47,586 - 104,689; Full time

Job summary

Georgetown University Medical Center's Lombardi Comprehensive Cancer Center seeks a Clinical Research Coordinator for oncology trials (Phase I-III). The role coordinates trials across their lifecycle, ensuring protocol integrity and patient safety on campus.

You will recruit and screen participants, obtain informed consent, manage data in CTMS, coordinate procedures, and liaise with investigators, sponsors, IRB, and study monitors while upholding HIPAA and GCP guidelines.

Qualifications

• Bachelor's degree in a scientific or health field is required.
• Two years of clinical research experience preferred.

Responsibilities

• Coordinate trials through the lifecycle and maintain protocol integrity.
• Assist with recruitment, screening, informed consent, and data collection.
• Coordinate study procedures while ensuring patient safety and GCP compliance.
• Support care continuum including triage, symptom management, and patient communication.
• Collect research specimens per protocol.
• Educate participants about trial participation, testing, and side effects.
• Maintain CTMS with patient data and dates for financial management.
• Collaborate with Data Managers and resolve queries.
• Report serious adverse events per policy.
• Serve as liaison with hospital staff, IRB, auditors, and sponsors.

Skills

Independent work

Attention to detail

Prioritization

Education

Bachelor's Degree in a scientific or health related field

Job description

Job Overview

As a clinical research coordinator for phase I, II, and III oncology clinical trials conducted in the 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.
• 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.
• 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.

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.
• Two (2) 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. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation .

$67,779.14 range $47,586 - $104,689 USD Annual

Pay Range:

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.

Current Georgetown Employees:

If you currently work at Georgetown University, please exit this website and login to GMS ( gms.georgetown.edu ) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.