Clinical Research Coordinator II, Lombardi Comprehensive Cancer Center – Georgetown University Medical Center

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Requirements

Clinical Research Coordinator II, Lombardi Comprehensive Cancer Center – Georgetown University Medical Center

Georgetown’s Lombardi Comprehensive Cancer Center (LCCC) seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of cura personalis - care for others. We seek to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists for the future.

Job Overview

The Clinical Research Coordinator II serves as clinical research coordinator for phases I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center – in duties that include but are not limited to:

• Administer overall coordination of assigned clinical trials throughout the trial lifecycle
• Collaborate with investigators and 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 bodies
• 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 an expert liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors
• Provide guidance and training to entry level coordinators and other CRMO staff
• Assist with CRMO special projects, SOP development, and process improvement
• Perform all duties in accordance with applicable laws and regulations
• Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs
• Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP

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, and Laboratory Technicians
• External department clinicians and staff - Infusion Nurses, Oncology Pharmacists, and hospital staff
• Clinical trial sponsors, auditors, and study monitors

Qualifications

• Bachelor’s degree in a scientific or health related field - preference for Master’s degree
• 3 to 5 years of related experience
• Strong candidates exhibit ● Ability to work independently and function within a team ● Strong attention to detail ● Reliability and ability to prioritize competing responsibilities

Work Mode: 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 and AAP positions can be found on the Department of Human Resources Mode of Work Designation .

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume  for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here  for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected] .

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer  fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law .

Benefits:

Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website .