Clinical Research Coordinator

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

Job Overview

The Clinical Research Coordinator II (CRCII) is the lead coordinator on multiple transplant (liver, kidney, pancreas, bowel) and GI clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Trials Supervisor as well as the Research Director.  The CRCII is responsible for the implementation of their assigned portfolio of studies, including regulatory submissions, data abstraction/entry/management, participant screening and enrollment, and study management.  Given the role is an intermediate level position, the coordinator will manage moderate to high-level complexity studies.  The role involves supporting the research on-call rotation amongst the research team to support transplant surgeries, enrollments, and the sample collection program.

Work Interactions

The Clinical Research Coordinator II works under the direct supervision of the Clinical Trials Supervisor in partnership with the oversight of Research Director and conducts the studies under direct oversight of the Principal Investigators (PIs).  This individual will interact directly with patients, research participants, and their families.  They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs financial office, research development services, respective grants managers, and serve as primary point of contact with sponsors, CROs, and IRBs.

Requirements and Qualifications

• Bachelor's degree in a scientific or related field with at least 3 years CRCI or equivalent clinical research experience.  An equivalent combination of education and experience may be substituted.

• Working knowledge of the federal regulations and federal agencies including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), as well as familiarity with the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP).

• Strong organizational, critical thinking, and problem-solving skills.

• Working knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance, both industry and non-industry.

• Excellent demonstrated interpersonal, verbal, and written communication skills.

• Strong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications.

Preferred

• Experience with OnCore (Clinical Trials Management System).

• Certified clinical research certification (SoCRA or ACRP) preferred and required within one year of eligibility.

Work Mode Designation

The 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 and AAP positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$21.16 - $35.29

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.

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