Clinical Research Coordinator I/II
- Seattle, WA
- Permanent
- Full-time
- Study Conduct / Clinical Research Practice
- Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols.
- Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines.
- Serve as project liaison, representing the project to other center departments, affiliated individuals or institutions, and outside organizations.
- On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff.
- Initiation and completion of Central Startup for both industry sponsored and PI initiated studies
- Collaborate with investigators and coworkers to ensure completion of study activities
- Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct.
- Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects.
- Travel to University of Medical Center and the Fred Hutch Outpatient Clinic will be required for the enrollment of study subjects.
- Ensure accurate enrollment records are maintained and up to date.
- Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
- Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice.
- Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
- Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans.
- Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
- Prepare requests for research prices on study activities and coordinate the research billing start-up process.
- Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement.
- Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues.
- Provide input to the regulatory coordinator on protocol document submissions and continuing review reports.
- Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports.
- Perform retrospective chart review as required
- Travel for investigator meetings
- Will require weekends and holiday coverage for clinical studies.
- Other duties as assigned
Clinical Research Coordinator I
- 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 synthesis study conduct.
- Ability to apply judgement 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.
- All qualifications of Clinical Research Coordinator I, plus:
- Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections.
- Knowledge of clinical trials records, procedures, and computerized data processing systems.
- Ability to work with multiple data management systems including generating reports and sourcing data from systems.
- Ability to extract data from medical records.
- Bachelor's degree preferred
- Minimum five years of experience in a research environment with regulatory or human research protections.
- Previous work experience in conducting interventional clinical trial trials
- Computer experience including electronic various CRF platforms, MS Office including Excel, Outlook, PowerPoint
- Excellent written and oral communication skills, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team.
- Previous experience in oncology research and clinical data collection is preferred
- Knowledge using REDCap databases.
- Desired Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification
- 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.