Clinical Research Coordinator II
About The Position
The Clinical Research Coordinator II (CRC II) is a lead coordinator on multiple surgical services (General Surgery, Burn, Breast, Endocrine, Trauma, Colorectal, and Surgical Oncology) and possibly transplant clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Research Nurse Manager in collaboration with a Research Director. The CRC II is responsible for the implementation of their assigned portfolio of clinical 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 surgical and transplant services and their enrollments. The Clinical Research Coordinator II works under the direct supervision of the Clinical Research Nurse Manager in collaboration with the Research Director and conducts 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 the sponsors, CROs, and IRBs.
Requirements
- Bachelor's degree in a scientific or related field with at least 3 years CRC I 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.
Nice To Haves
- Experience with OnCore (Clinical Trials Management System).
- Certified clinical research certification (SoCRA or ACRP) preferred and is expected within one year of eligibility.
Responsibilities
- implementation of their assigned portfolio of clinical studies
- regulatory submissions
- data abstraction/entry/management
- participant screening and enrollment
- study management
- supporting the research on-call rotation amongst the research team to support surgical and transplant services and their enrollments
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
