Quality Assurance Coordinator

Overview

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 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 of accurate service 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 to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Responsibilities

• Study Compliance: Use high level organizational skills and clinical research experience to review clinical protocol and study manuals for accuracy and feasibility. Extract pertinent details for entry into Fred Hutch CRSP LIMS system. Maintain up to date database information to ensure accurate processing of study samples.
• Quality Control: Maintain relevant study documents on behalf of CRSP including but not limited to protocols, study/laboratory manuals, amendments, etc. Update internal study documents as changes occur. Perform periodic verification of data entry into LIMS system. Works with Core Director and Clinical Research Team to investigate any study compliance concerns pertaining to CRSP.
• Collaboration: Advise PIs/Study teams on protocol development to ensure correct specimen workflows and processing procedures. Prepare for and attend all relevant Site Initiation Visits to allow information exchange in optimizing CRSP-relevant portions of clinical protocols/study manuals. Establish and maintain positive working relationships with investigators and study managers, soliciting feedback to establish present and future needs and helping as 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 to identify and recommend ways to improve CRSP Team efficiency and clinical research compliance. Provide support for specimen processing and other laboratory activities. Other duties as assigned by the CRSP Director.

Qualifications

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.

PREFERRED QUALIFICATIONS:

• Bachelor's degree (preferably in Biology or health sciences) and 1-2 years clinical research experience, OR
• Associate degree and 3+ years of experience
• Clinical trial knowledge/experience and demonstrated understanding 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 of quality assurance and feasibility as applied to clinical research studies.
• Familiarity with basic laboratory information management system concepts.
• Knowledge of basic clinical protocol design and terminology.
• Knowledge of basic specimen acquisition processing and terminology.
• Ability to work on multiple tasks and establish priorities.

The annual base salary range for this position is from $80,172 to $114,941, 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).