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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

Since 2001, Fred Hutch has led an array of distinctive research activities in partnership with colleagues in South Africa to accelerate the development of a preventive HIV vaccine and improve the diagnosis, prevention, and treatment of cancer and infectious diseases worldwide. In 2013, Fred Hutch opened the state-of-the-art Cape Town HVTN Immunology Laboratory (CHIL) to serve as a base for HIV vaccine trials, and more recently COVID-19 vaccine trials, in South Africa. 

The Clinical Laboratory Operations QA Associate I reports to the Lead Clinical Laboratory Operations QA Associate, and is responsible for creating, developing, monitoring and managing quality systems that support ongoing Laboratory Operations of specimen processing for HVTN clinical trials across Southern Africa. A person in this position works on complex problems requiring data analysis and the ability to perform an in-depth evaluation of regulations and policies in selecting methods and techniques for obtaining results. The Quality Assurance Associate has additional responsibilities in leading project efforts and management of quality systems.

The focus of responsibilities for the HVTN QA Associate I is to provide oversight, coordinate and facilitate clinical site specimen processing and clinical testing laboratory projects and programs for the HIV Vaccine Trial Network (HVTN) Laboratory Center Division.

Responsibilities

Project Management, coordination, support and implementation (30%)

• Communicate as needed with Division of AIDS or DAIDS contractors.
• Manage clinical site laboratory supply program including resourcing new supplies and vendors.
• Provide LDMS (centralized laboratory data management system) support to sites; provide program input to the program developer, Frontier Sciences.
• Provide input and support to for HIV/AIDS Network Coordination (HANC) laboratory programs, including the Laboratory Focus Group.
• As needed and working in close collaboration with other HVTN staff, participate in teams that support the implementation of HVTN clinical trials in Southern Africa.
• Other duties and assignments as requested for the overall performance of the department and company.

Safety Management, Quality control, Quality Assessment Coordination (40%)

• Oversee and support assigned clinical site laboratories for HVTN and client protocol preparation; includes provision of clinical site training, ensuring appropriate supplies on site, developing and communicating protocol-related laboratory practices, determining site equipment needs, and monitoring Good Clinical Laboratory Practice compliance.
• Assist clinical site laboratories with implementation of their tailored Quality Assurance plans, including but not limited to the writing and use of laboratory SOPs, establishment of equipment maintenance programs, and proper data and specimen management.
• Review and analyze clinical site laboratories workload, performance and adherence to approved Quality Assurance Program.
• Provide oversight for Peripheral Blood Mononuclear Cell (PBMC)/serum/plasma processing and cryopreservation training and certification program.
• Provide PBMC External Quality Control (EQC) program support including analysis, interpretation and reporting to sites. Review adequacy of site response on EQC reports.
• Provide input and support to HVTN and client protocol teams regarding local laboratory testing/methodologies, processing, storage and shipping of specimens.

Clinical Research Support, quality assurance, protocol adherence (30%)

• Provide clinical site laboratory support, training and protocol laboratory practice reviews through regular site visits, conference calls or other appropriate media; adapt communication styles based on targeted audience and topic.
• Develop and implement clinical site training programs and tools for new specimen processing techniques that include quality assurance practices.
• Work with the Network Specimen Manager to track specimen transport and related quality issues.
• Coordinate, participate and support the efforts of the HVTN Laboratory Program and perform additional activities as necessary.

Other duties, as required.

Qualifications

EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED

• S/BA/ B-Tech required in a medical scientific field registered with relevant professional body
• At least 5 years of experience as a medical laboratory technologist/ scientist or equivalent
• At least 3 year of experience in quality assurance with understanding of Quality Management Program
• Experience in Good Clinical Laboratory Practices (GCLP), clinical laboratory quality assurance.
• Certified Medical Technologist preferred.
• Experience in clinical safety laboratory management, PBMC (peripheral blood mononuclear cell) processing, sample storage and clinical trial experience
• Understanding of HIV diagnostics testing preferred.
• Should be able to handle challenging workloads and multiple concurrent projects.

COMPETENCIES / JOB SPECIFICATIONS REQUIRED TO DO THE JOB

• Understanding of HIV diagnostics testing.
• Demonstrated experience with PBMC (peripheral blood mononuclear cell) processing, sample storage and clinical trials.
• Incident management experience, Laboratory deviations and monitoring corrective and preventative actions.
• Audit and Good Clinical Laboratory Practice (GCLP) experience.
• Good numeracy, literacy, and organizational skills.
• Computer skills – including Microsoft Word, Excel, PowerPoint and other laboratory-specific programs.
• Good interpersonal communication and time management skills.
• Process improvement and program management skills.
• Flexibility around working hours to accommodate operational needs, be willing to travel (up to 50%) as needed, and work some evenings and weekends
• Ability to think innovatively, manage multiple tasks, and excel under pressure, collaborating with different stakeholders to identify and resolve challenges.
• Ability to take initiative and work independently as well as in teams, using extensive multitasking skills.
• Effective communication and interpersonal skills; works well in a team environment and with international co-workers/collaborators.
• Advanced administrative abilities and high attention to detail.
• Exceptional interpersonal and communication skills (oral, written and listening), with the ability to effectively liaise with stakeholders at all levels.

Protection of Personal Information Act (POPIA) Consent to Use and Collection of Personal Information, Including Consent to Background Check.