Clinical Research Operations Specialist

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here.
At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.

Careers Start Here.
This position will provide and manage support for clinical trial start-up in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics of new clinical trials and creating start-up plans including review requirements and timelines. The position will work closely with other Clinical Research Support start-up specialists to manage start-up projects. The position will also work closely with Cancer Consortium study teams to provide compliant, patient-ready clinical trials. This position will develop tools and best practices for study start-up. This position requires expert understanding of clinical research resources required to conduct clinical trials.

- Review and assess new clinical trials to identify operational, regulatory and resource requirements.
- Work closely with study teams to create and maintain the agreed upon start-up plan.
- Develop and negotiate appropriate clinical trials budgets within tight timelines.
- Prepare and manage regulatory documentation with various internal departments and external sponsors.
- Identify and generate tools and/or templates for study teams to use based on requirements identified during the start-up plan.
- Maintain direct communication with faculty members, clinic departments, funding sponsors, and research collaborators in support of the overall research plan; report start-up progress to PIs and study staff ensuring transparency during the process and identifying any issues.
- Develop and maintain procedures for the department and Consortium with the goal of standardization, increased efficiency, and compliance.
- Collaborate with Consortium members, clinic partners, and leadership to establish study start-up best practices.
- Stay current with trends in clinical research; makes recommendations to leadership.
- Participate in study implementation related process improvement efforts on behalf of the Consortium including implementation of technology solutions.
- Develop tools to assist study teams with start-up process.

Experience and Abilities:
- 3-5 years starting and managing clinical trials, preferably oncology trials.
- Preparing, negotiating and managing industry sponsor clinical trials budgets.
- Forecasting and meeting deadlines.
- Preparing and/or reviewing study startup documents (i.e., IRB applications).
- Working across different academic institutions to facilitate research projects.
- Working with multi-disciplinary teams.
- Communicating with all levels of a research organization.

Knowledge and Skills:
- Bachelor's Degree.
- 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.

To apply for this position, please CLICK HERE

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