The clinical research operations specialist position will facilitate and manage study startup for oncology clinical trials in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics, financial and implementation requirements and managing startup timelines of new industry-sponsored clinical trials. This position will work closely with internal and external regulatory and fiscal specialists to manage startup 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 facilitate centralized study startup standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of project and timeline management, understanding of the research process, operationalizing industry-sponsored clinical trial protocols, and knowledge of financial resources required to conduct clinical research.
Project manage the study startup timeline and operations (including budget development, negotiations and clinic implementation) in continuity with centralized study startup teams standards and practices in support of larger consortium and department strategic initiatives.
Review and assess new clinical trial documents to identify operational and resource requirements.
Identify research costs, develop comprehensive budgets and maximize negotiation of industry sponsored clinical trials that support protocol implementation and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team effort, etc.).
Prepare, submit, and manage internal financial and clinic implementation processes on behalf of the study team.
Initiate and facilitate meetings with industry sponsors and study teams (i.e., review of startup timelines goals, dependencies, milestones and comprehensive integration of protocol requirements for study implementation).
Maintain source documentation, correspondence and startup records throughout the startup process (i.e. from study kickoff to study handoff) in alignment with centralized study startup standard practices.
Monitor and maintain standard internal trackers, timelines and logs to maximize transparency and efficiency among central startup members.
Work closely with Startup Operations Manager, CRS Startup Team members, consortium members and study teams to support comprehensive study startup process, goals and deadlines.
Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure protocol requirements can be met upon study activation.
Report startup progress to industry sponsors, investigators and study teams weekly to ensure transparency throughout the startup process.
Experience and Abilities
Minimum 2-3 years’ experience coordinating industry-sponsored clinical trials, preferably oncology trials
Preparing and/or reviewing study startup documents
Working across different academic institutions to facilitate research projects
Working with multi-disciplinary teams
Forecasting and meeting deadlines
Communicating with all levels of a research organization
Knowledge and Skills
Clinical research related certification preferred
Familiarity with project management tools and techniques
Strong verbal and written communication skills
Knowledge of applicable local, state and federal regulations and guidelines
Basic knowledge of clinical trial budgets
Knowledge of Outlook, MS Teams, Microsoft Office
This positoin is fully Remote: As a part of the the application process, PLEASE SUBMIT A COVER LETTER DETAILING WHY YOU ARE INTERESTED IN THIS POSITION AND HOW YOUR EXPERIENCE IS RELATIVE.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
Our Commitment to DiversityWe 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 firstname.lastname@example.org or by calling 206-667-4700.
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