Clinical Research Coordinator I

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Clinical Research Coordinator I coordinates day-to-day activities for clinical research protocols for Infectious Disease Sciences Program faculty. The role participates in planning, coordinating, and implementing complex investigator-initiated, industry-sponsored, and cooperative group studies involving human subjects for three faculty members. The coordinator works under faculty supervision, exercises a high level of independence within protocol and institutional requirements, collaborates with multidisciplinary teams, and may guide other study staff. The position supports study conduct, protocol development, budgeting and billing, and regulatory compliance. Responsibilities include recruiting and following participants, coordinating visits and specimens, maintaining study records and supplies, supporting data collection and quality, managing research billing, and assisting with regulatory submissions and reports. Travel to University of Medical Center for subject enrollment and travel for investigator meetings may be required. Weekend and holiday coverage is required for clinical studies.

Requirements

High school diploma or equivalent.
At least one year of 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 when interpreting regulations, determining impacts, and deciding when to escalate questions and concerns.
Organizational skills, attention to detail, problem-solving ability, and ability to prioritize multiple competing tasks in a dynamic environment.
Excellent written and oral communication skills, leadership ability, and flexibility to collaborate with a multidisciplinary team.
Computer experience, including electronic case report forms and Microsoft Office applications such as Excel, Outlook, PowerPoint, and Access.
Ability to travel to University of Medical Center for participant enrollment and to investigator meetings as required.
Availability for weekend and holiday coverage for clinical studies.

Nice To Haves

Previous experience in oncology research and clinical data collection.
Knowledge of REDCap databases.
Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification.
EPIC experience.
Oncology clinic experience.

Responsibilities

Plan, coordinate, and implement investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects.
Independently carry out daily responsibilities for clinical trials and non-intervention protocols, and coordinate research and administrative activities to meet project timelines.
Serve as project liaison with center departments, funding sources, affiliated individuals or institutions, and outside organizations.
Act as the main protocol resource for investigators or sponsors, research subjects, laboratories, monitors, primary care teams, and investigational pharmacy staff on assigned projects.
Collaborate with investigators and coworkers to complete study activities; train others as needed and develop standard operating procedures or other study documents.
Screen, recruit, enroll, and follow research subjects; complete case report forms, place physician orders, coordinate study visits, and communicate with care teams, pharmacy staff, and subjects.
Maintain accurate and current enrollment records.
Coordinate specimen collection, transport, processing, storage, and shipment according to protocol requirements.
Track and maintain research supplies; create source documents or case report forms as needed; review case report forms for completeness, accuracy, and Good Clinical Practice compliance.
Identify and report adverse events in accordance with protocols, regulatory guidelines, and institutional policy.
Help develop and review protocols for feasibility and collaborate on study budgets and implementation plans.
Develop and maintain study implementation tools, including data collection tools, reference materials, and study-specific orders; revise and use these tools as needed.
Prepare requests for research prices and coordinate research billing start-up; review, reconcile, and approve research study bills; work with IDS fiscal staff to support accurate billing and reimbursement.
Facilitate protocol monitoring visits and work with study monitors to resolve data discrepancies and procedural issues.
Provide input to the regulatory coordinator on protocol submissions and continuing review reports; prepare or assist with consent forms, continuing review reports, protocol modifications, serious adverse event reports, and other study reports.
Perform retrospective chart reviews as required.
Travel for investigator meetings and to University of Medical Center for enrollment of study subjects.
Provide weekend and holiday coverage for clinical studies.
Perform other duties as assigned.