Fred Hutchinson Cancer Center - Seattle, WA

posted 3 days ago

Full-time - Entry Level
Seattle, WA

About the position

The Clinical Research Coordinator I at Fred Hutchinson Cancer Center plays a crucial role in the logistical management of clinical trials, ensuring compliance with study protocols and regulatory guidelines. This position is part of a central Clinical Trial Coordination team and supports specialized oncology research portfolios, contributing to the advancement of cancer treatment and research.

Responsibilities

  • Coordinate and assist in carrying out daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
  • Assist in disseminating study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
  • Assist with patient enrollment and participation by reviewing study candidates' medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
  • Schedule patient clinic visits and ongoing study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires, ensure drug self-administration accountability with patients and perform non-clinical ECGs.
  • Complete clinical requisition forms as instructed, assemble kits for patient visits, 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.
  • Assist in preparing for and coordinating monitoring visits and assist in responding to queries and other requests from study monitors.
  • Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations.
  • May travel to attend industry-sponsored investigator meetings.
  • May assist with maintaining appropriate source documentation and/or performing case report form data entry.
  • Other duties as assigned.

Requirements

  • High school diploma or equivalent.
  • Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
  • Demonstrated knowledge of how to synthesize study conduct.
  • Ability to apply judgment in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
  • 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.

Nice-to-haves

  • Associate or bachelor's degree.
  • Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
  • Two 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.
  • Knowledge of clinical trials records, procedures, and computerized data processing systems.
  • Ability to extract data from medical records.

Benefits

  • Medical/Vision insurance
  • Dental insurance
  • Flexible spending accounts
  • Life insurance
  • Disability insurance
  • Retirement plan
  • Family life support
  • Employee assistance program
  • Onsite health clinic
  • Tuition reimbursement
  • Paid vacation (12-22 days per year)
  • Paid sick leave (12-25 days per year)
  • Paid holidays (13 days per year)
  • Paid parental leave (up to 4 weeks)
  • Partially paid sabbatical leave (up to 6 months)
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