The Cancer Clinical Research Coordinator III (CRC III) will facilitate the planning, coordination, and implementation of Community Clinical Oncology Program (CCOP) and industry-sponsored studies involving human subjects. The CRC III 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.
A Clinical Research Coordinator (CRC) III is a senior-level coordinator that works under the supervision of the Clinical Research Program Manager and is responsible for a portfolio of complex interventional clinical protocols.
The incumbent will be required to perform responsibilities with a high level of independence.
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 and development of source documents
- Eligibility verification
- Proper standard of research billing
- Ensuring site quality
Subject care requirements may include:
- Appointment scheduling
- Records review
- Treatment coordination
- Collecting vital signs
- Subject health assessment
- Telephone triage/screening
- At all times the CRC will ensure protocol compliance and subject safety
The Clinical Research Coordinator may also perform phlebotomy, specimen processing using universal precautions when appropriate and consistent with licensure and participate in process improvement activities, root cause analysis and create corrective and preventive action (CAPA) plans. In addition this individual will work with the Principal Investigator to manage the daily operations of their research portfolio. This includes assist with the identification and feasibility assessment of new studies, reviewing financial reports and assist the clinical research team to assure the CAPA’s created are addressing the problem(s) identified. The Clinical Research Coordinator 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, this position may provide guidance, mentorship or supervision of a Research Assistant or Clinical Research Coordinator I & II.
- Five years of experience in clinical research is required
- A Bachelor’s degree and ACRP or SOCRA Certification is strongly preferred
- May substitute a Masters in Clinical Research or related field or MD for the two years of clinical research experience
- The ideal candidate will possess superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
- The incumbent will have a collaborative focus; flexibility, ability to work independently, excellent organizational skills, and proficiency in MS office