Overview

This position will manage industry clinical trial startup in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new industry-sponsored clinical trials and creating start-up plans including review requirements and timelines. This position will work closely with internal and external regulatory and fiscal specialists to manage start-up tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met.

This position will manage centralized study start-up standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of the research process for industry-sponsored clinical trials, knowledge of start-up requirements, clinic implementation, and financial resources required to conduct clinical research.

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

Responsibilities

• Project manage the startup timeline and operations from pre-startup workflow through activation on behalf of research groups.
• Manage 15-week startup timeline, ensuring that all financial, clinic implementation and contract requirements are executed accurately and expeditiously. Engage clinical trial office, clinic, regulatory and contracting entities throughout the study startup lifecycle to ensure adherence to metric timeline goals.
• Develop budgets and manage budget negotiations with external partners on behalf of research groups in alignment CRS central startup standards in support of larger CRS strategic initiatives.
• Lead clinic implementation planning, operations, and logistics with internal and external stakeholders on behalf of research groups in support of larger CRS strategic initiatives.
• Create comprehensive budgets and ensure adequate support for protocol implementation, and institutional requirements (i.e., submit waivers requests for institutional fees as applicable, non-routine procedure and administrative costs, study team time and effort, etc.).
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Minimum 3-5 years' experience coordinating industry-sponsored clinical trials, preferably oncology trials
• Bachelor's Degree or equivalent years of experience
• Demonstrated ability to deliver outcomes in fast paced environments.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Demonstrated skills in critical thinking and problem solving.
• Ability to process complex documents and extract key information.
• Working with multi-disciplinary teams
• Forecasting and meeting deadlines
• Communicating with all levels of a research organization
• Basic knowledge of clinical trial budgets
• Familiarity with project management tools and techniques
• Familiarity with CTMS and systems to support workflow & metrics.
• Proficiency in use of Excel, MS Word, and Acrobat
• Strong verbal and written communication skills
• Strong attention to detail and ability to work according to CRS central office standards and best practices.
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders
• Effectively able to communicate and demonstrate accountability in a remote setting.

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred.
• Previous experience with oncology trials.

The annual base salary range for this position is from $80,172 to $109,470, 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).

Additional Information