Clinical Research Coordinator II

• Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
• Develop and maintain tools for study implementation, including data collection tools, reference materials and specific study orders; revise and utilize tools as necessary.
• Create and disseminate study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
• Coordinate patient sample receipt and testing by reviewing enrolling sites’ information, sample quality and eligibility, ensuring complete documentation, and maintaining accurate records on samples, quality, workflow, data, and variance/deviation tracking per FDA-IDE requirement.
• Ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities as relevant.
• Complete clinical requisition forms as instructed, assemble kits for patient samples, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Identify, track and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
• Act as protocol liaison with clinical teams, patients, and providers on study related topics.
• Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations. May travel to attend investigator meetings.
• Assist with maintaining appropriate source documentation and/or performing data entry, data analysis, and data auditing.
• Other duties as assigned.

• High School diploma
• Minimum two years’ experience in a clinical research, clinical laboratory, or cancer registry environment with regulatory or human research protections.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
• Ability to work with multiple data management systems including generating reports and sourcing data from systems.
• Ability to extract data from medical records.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

• Associate or bachelor’s degree or equivalent.
• Certified Clinical Research Coordinator (CCRC), certification as Clinical Research Professional (SOCRA), or certification in Cytogenetics or Molecular Testing by ASCP (CpG or MB).
• Demonstrated knowledge of how to synthesize study conduct.
• Minimum five years of experience in a research environment with regulatory or human research protections.
• Previous experience working with NIH, FDA and OHRP regulations and medical terminology.

Fred Hutchinson Cancer Center