Quality Assurance Coordinator

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 worlds 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 worlds 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 Specimen Processing Laboratory (CRSP) Quality Assurance Coordinator ensures feasibility and compliance with relevant clinical research requirements and conducts quality control and assurance activities. This role will interact with the various departments and staff engaged in clinical research such as investigators study teams and laboratory and clinic staff. Additionally this position will ensure continuity ofaccurateservice through quality control documentation. Role will oversee the data input into the CRSP Laboratory Information Management System (LIMS) and generate metrics upon request.

At Fred Hutchinson Cancer Center all employees are expected todemonstratea commitment toour values of collaboration compassion determination excellence innovation integrity and respect.

• Study Compliance: Use high level organizational skills and clinical research experience to review clinicalprotocoland study manuals for accuracy and pertinent details for entry into Fred HutchCRSPLIMS up to date database information to ensureaccurateprocessing of study samples.
• Quality Control: Maintainrelevant study documents on behalf ofCRSPincluding but not limited to protocols study/laboratory manuals amendments etc. Update internal study documents as changes occur. Perform periodic verification of data entry intoLIMSsystem. Works with Core Director and Clinical Research Team to investigate any study compliance concernspertaining toCRSP.
• Collaboration: AdvisePIs/Study teams on protocol development to ensure correct specimen workflows and processing for and attend all relevant Site Initiation Visits to allow information exchange inoptimizingCRSP-relevant portions of clinical protocols/study manuals. Establish andmaintainpositive working relationships with investigators and study managerssolicitingfeedback toestablishpresent and future needs andhelpingas requested.
• Operations Oversight: Work with LIMS development team to continue to refine and improve study onboarding and management of specimen submission. Train CRSP and/or study staff on appropriate standard operating procedures related to CRSP.
• Teamwork: Evaluate data and use direct observations toidentifyand recommend ways to improve CRSP Team efficiency and clinical research support for specimen processing and other laboratory duties as assigned by theCRSPDirector.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.

PREFERRED QUALIFICATIONS:

• Bachelors degree(preferably in Biology orhealth sciences)and1-2yearsclinical researchexperienceOR
• Associate degree and 3 years of experience
• Clinical trial knowledge/experience anddemonstratedunderstanding of required materials such as clinical protocols and laboratory manuals provided by pharmaceutical companies for clinical investigations.
• Ability to critically review clinical protocols and complex laboratory manuals.
• Demonstrated performance to provide leadership training and problem-solving.
• Represent CRSP during meetings or other communications with investigators study team members and sponsors.
• Understanding ofquality assurance and feasibility as applied to clinical researchstudies.
• Familiarity with basic laboratory information management system concepts.
• Knowledgeofbasic clinical protocol design and terminology.
• Knowledge of basic specimen acquisition processing and terminology.
• Ability to work on multiple tasks andestablishpriorities.

The annual base salary range for this position is from $80172 to $114941 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

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).