IDCRC Laboratory Operations Unit (LOU) - Protocol Coordinator I-II

Job ID
24160
Type
Regular Full-Time
Location
US-WA-Seattle
Category
Project Management

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.

 

The Infectious Diseases Clinical Research Consortium’s (IDCRC) goal is to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID.  The Laboratory Operations Unit (LOU) leads the development, implementation and evaluation of the laboratory research essential to the successful execution of the IDCRC research agenda. The IDCRC’s mission is to facilitate the process of testing candidate vaccines, diagnostics, therapeutics, and other interventions in clinical trials. The organization conducts Phase 1 through Phase 4 vaccine and treatment trials, including clinical studies in collaboration with industry partners.

Responsibilities

The focus of responsibilities for the LOU Protocol Coordinator I/II is to support and coordinate IDCRC protocols (clinical trials) on behalf of the LOU in conjunction with other IDCRC stakeholders. LOU Protocol Coordinator I vs II designation will be based on candidate’s qualifications and related experience. The incumbent works under the direction of the Associate Director of the LOU. The LOU Protocol Coordinator will work with protocol teams, laboratory investigators, protocol-specific data management teams, clinical trial sites, and study sponsors in support of all protocol laboratory operations during all phases of the protocol (development, implementation, closeout).  They will participate on IDCRC protocol team calls and meetings, prepare written reports and oral presentations, and:

 

  • Represent the IDCRC LOU on protocol teams.
  • Establish or confirm endpoint assays and corresponding specimen needs for each study. Contribute to completion and maintenance of the central assay plan.
  • Serve as a LOU liaison to other protocol team members, IDCRC units, DMID, affiliated individuals or institutions, and outside organizations.
  • Working with the LOU team, contribute to the preparation of operational plans for specimen collection and processing at the clinical research sites
  • Working with the LOU team, create and maintain study materials for laboratory-related procedures, including instructions and documents for the clinics and processing laboratories.
  • Contribute to drafting and reviewing case report forms related to primary specimen collection.
  • Prepare and maintain laboratory study cost estimates.
  • Participate on IDCRC conference calls and meetings and contribute to agenda items.
  • Troubleshoot operational details of protocols with the protocol teams and protocol-specific data management teams.
  • Provide ongoing per-protocol consultation for laboratory-related issues to protocol teams, consortium partners, sponsors, and internal partners.
  • Partnering with LOU QA Associate, contribute to ongoing monitoring and collaboration with sites and laboratories, including, but not limited to, providing trainings to ensure quality specimen collection and handling.
  • As necessary, assist with protocol funding proposals and the IDCRC annual progress report. 

 

 

Qualifications

MINIMUM QUALIFICATIONS PROTOCOL COORDINATOR I:

  • B.A/B.S. in a medical science field with minimum 2-4 years of experience with expertise in human clinical trials, immunology, virology and/or pharmacokinetics/pharmacodynamics.
  • Work under minimal supervision, and ability to create and manage project schedules, including tasks, deliverables, milestones, and schedules.
  • Strong background in collaborative team leadership and project completion, along with excellent written and oral communication is required.
  • Proficiency with MS Office Suite, especially Outlook, Teams, and SharePoint. Advanced experience with Microsoft Excel highly preferred (ability to create and maintain pivot tables, automated calculations, other complex data analyses).
  • Experience using Zoom or other teleconferencing software.

 

MINIMUM QUALIFICATIONS PROTOCOL COORDINATOR II:

  • B.A/B.S. in a medical science field with minimum 4 years’ experience with expertise in human clinical trials, immunology, virology and/or pharmacokinetics/pharmacodynamics.
  • Three years of experience in laboratory management required. 
  • Experience in clinical trials management preferred. 
  • Work under minimal supervision, and ability to create and manage project schedules, including tasks, deliverables, milestones, and schedules.
  • Strong background in collaborative team leadership and project completion, along with excellent written and oral communication is required.
  • Proficiency with MS Office Suite, especially Outlook, Teams, and SharePoint. Advanced experience with Microsoft Excel highly preferred (ability to create and maintain pivot tables, automated calculations, other complex data analyses).
  • Experience using Zoom or other teleconferencing software.

 

PREFERRED QUALIFICATIONS:

  • MS. in a medical science field with minimum 2 years’ experience with expertise in human clinical trials, immunology, virology and/or pharmacokinetics/pharmacodynamics.
  • Background in laboratory assays such as ELISA, ECLIA, T and B cell flow cytometry, PCR, ELISPOT, neutralizing antibodies, pathogen genome sequencing, pharmacokinetics, pathogen diagnostics and/or pre-clinical trials.
  • Prior experience as a project manager, laboratory technician, medical technologist, or research associate a plus.
  • Smartsheet experience.
  • Experience in clinical trial operations management.
  • Experience with GLPs and GCPs, CLIA and/or other laboratory certifications a plus.
  • Experience with international protocols.

 

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

 

PROTOCOL COORDINATOR I:

The annual base salary range for this position is from $64,233 to $96,349, and pay offered will be based on experience and qualifications.

 

PROTOCOL COORDINATOR II:

The annual base salary range for this position is from $74,358 to $111,536, and pay offered will be based on experience and qualifications.  

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). 

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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