Clinical Research Coordinator - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

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Requirements

Clinical Research Coordinator - Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

The Lombardi Comprehensive Cancer Center , part of Georgetown University Medical Center , 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 the whole person.” Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and northern New Jersey.

Job Overview

The Clinical Research Coordinator serves as clinical research coordinator for clinical trials conducted at the Georgetown Medical Center and Lombardi Comprehensive Cancer Center. Incumbent duties include, but are not limited to:

• Administer overall coordination of assigned clinical trials throughout the trial lifecycle
• Assist with the development and revision of research protocols and supporting documentation for submission to Georgetown University (GU) and MedStar Health (MedStar) Institutional Review Board and any external IRB, as needed
• Collaborate with investigators and other study team members by participating in the recruitment of study participants; conduct participant screening and enrollment procedures and document eligibility data to support protocol compliance
• Interface with study participants and obtain and document informed consent according to study protocol, institutional policies, and regulatory bodies
• Coordinate or conduct study-related procedures and assessments while maintaining protocol integrity and participant safety and in accordance with Ethical Principles and Guidelines for the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
• Coordinate the collection of research specimens per protocol requirements
• Schedule/conduct/maintain required training for involvement with clinical trials
• Regularly update the Clinical Trials Management System (CTMS) with participant information and key dates to support responsible financial management of clinical trials, as appropriate
• Collaborate with Investigators and Data Manager(s) to assure documentation for the clinical trial is complete and accurate; assist with query resolution in a timely manner
• Document study-related expenditures and collaborate with Financial Analyst(s) to assist study investigators manage sponsored funds; assist with expense queries in a timely manner
• 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
• Assist with other 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, participant confidentiality/HIPAA, and GCP.

Work Interactions

• Principal Investigators, Physicians, Clinicians
• External department clinicians and staff
• Clinical trial sponsors, auditors, and study monitors

Requirements and 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
  • Working knowledge of REDCap.
  • Database management experience
  • Human subject’s recruitment experience

'Work Mode Designation

This position has been designated as Hybrid. 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 website: https://hr.georgetown.edu/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 resume for each position of interest for which you believe you are qualified. 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 .