The Clinical Research Coordinator II (CRC II) will facilitate the planning, coordination, and implementation of Community Clinical Oncology Program (CCOP) and industry-sponsored Oncology studies involving human subjects. The CRC II will have daily interaction with PIs, study staff, pharmaceutical sponsors, physicians, and other health care personnel as part of a cross-functional team working within Virginia Mason Medical Center and Benaroya Research Institute.
The Cancer Clinical Research Coordinator II (CRC) performs increasingly complex studies, test article (TA), disease or earlier phase studies.
Responsibilities may include:
• New study preparation
• Subject screening and recruitment
• Informed consent
• Subject history
• Adverse events
• Concomitant medication review
• Regulatory document filing
• Preparation for study monitor visits
• TA handling
• Completion of case report forms
• Maintenance of source documents
• Proper standard or research billing
• Ensuring site quality
Subject care requirements may include:
• Treatment coordination
• Collecting vital signs
• Subject health assessment
• Telephone triage/screening
• At all times the CRC will ensure protocol compliance and subject safety
The CRC may also perform phlebotomy, specimen processing using universal precautions when appropriate and consistent with licensure and participate in process improvement activities.
The CRC must maintain subject and document confidentiality at all times, understand and comply with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), Good Clinical Practices (GCP’s) and International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards, (IRB) and institutional policies and procedures. In some instances, may provide guidance or informal supervision of a Research Assistant or CRC I in the conduct of their study.
• Two years of experience in clinical research is required
• Bachelor’s degree and SOCRA or ACRP certification is strongly preferred (may substitute a Masters in clinical research or related field or M.D. for the two years of clinical research experience)