Clinical Research Coordinator I

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Clinical Research Coordinator will participate in the planning, coordination, and implementation of pharmaceutical sponsored and investigator-initiated clinical research studies for hematopoietic cell transplantation and hematologic malignancies.

Responsible for Investigational New Drug submissions, Institutional Review Board documentation, screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of clinical trial data in accordance with protocols subject to FDA oversight. Responsible for coordination of studies and the long-term follow-up activities associated with these protocols.

This is a 32 hour a week hybrid position.

This individual will work under the supervision of the Principal Investigator, will report regularly to the PI on study progress, and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/University of Washington system including the Transplant Clinical Service.

DUTIES BY CATEGORY

Principal Investigator Support:

• Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
• Assist the Principal Investigator (PI) with protocol development, revision, and study analysis.
• Protocol Implementation:
  
  • 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.
  • Initiate scheduling of patient clinic visits, and on-going study visits. Ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
  • Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
• Enrollment:
  
  • Screen potential subjects' medical records for study eligibility
  • Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
  • Education:
    Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
• Budget & Billing:
  
  • Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
  • Work with internal partners to obtain and submit budget and billing information.
  • Participate in the review of charges for patients on clinical trials to ensure billing compliance.
• Other Duties Which May Be Required:
  
  • Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
  • Ensure study drug self-administration and accountability with patients.
  • Administer study questionnaires.
  • Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies.
  • Maintain or assist in maintaining IRB correspondence and regulatory documentation. Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports.
  • Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
  • Coordinate monitoring visits and respond to queries and other requests from study monitors.
  • Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
  • Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.

MINIMUM QUALIFICATIONS:

• 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.

PREFERRED QUALIFICATIONS:

• Associate or bachelor's degree preferred.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• 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.
• 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.

The hourly pay range for this position is from $27.01 to $38.45 and pay offered will be based on experience and qualifications.

This position is not eligible for H-1B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, 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), and paid parental leave (up to 4 weeks). Paid time off is prorated for part-time positions.