Senior Clinical Data Coordinator

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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

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The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I III clinical trials in over 150 clinical sites around the world.

SCHARP is seeking a Senior Clinical Data Coordinator (Sr. CDC) who works to support the studies/projects to which they are assigned, contributing to the overall study data management. The Sr. CDC assists Clinical Data Managers in monitoring the collection, processing, routine review and quality control of study data across multiple EDC systems. They support the goals of each assigned study/project within the framework of each network, study or protocol operations andare responsible for managing assigned work within project timelines. They develop and maintain successful working relationships with their team and relevant research sites and ensure data integrity and quality within the scope of assigned projects. The Sr. CDC adheres to SCHARP Standard Operating Procedures (SOPs), Work Instructions (WIs), applicable clinical trial regulations, and study confidentiality requirements.

The Sr. Clinical Data Coordinator will work under the supervision and mentoring of departmental leadership but may receive guidance on specific tasks from Clinical Data Managers for assigned projects/studies. The Sr. CDC uses judgment in making decisions regarding routine data management tasks. They will refer all non-routine decisions for the management of study data to study/protocol leads and/or departmental leadership.

• Monitor study data to ensure the quality and completeness of the data submitted by Clinical Research Sites by implementing quality control procedures as appropriate
• Manager queries to sites across multiple EDC systems and act as a liaison for data management issues between SCHARP study teams and sites
• Generate QC reports and/or data listings for site review and correction as well as other data cleaning reports as required
• Attend assigned SCHARP study team meetings and conference calls
• May assist in the development of Case Report Forms and databases for assigned studies
• Perform User Acceptance Testing (UAT) as needed
• May assist in the maintenance of the study database including routine revisions or additions to include the design and/or modification of routine and existing study database edit check programs for assigned studies
• Assist in the creation and maintenance of study documentation (e.g. DMP)
• Assist in the maintenance of the Trial Master File as needed
• Assist in the review of SOPs and WIs
• The Sr. CDC is expected to be a subject matter expert in one or more areas to better assist the team in the above-stated goals and processes
• The Sr. CDC may also mentor junior Clinical Data Coordinators
• Perform additional tasks as appropriate and assigned

• Bachelors degree, preferably in a health-related or scientific discipline
• 3+ years experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator or equivalent role
• EDC experience preferred
• Working knowledge of Medidata Rave highly desirable
• Demonstrated expertise in relevant clinical data management activities
• Working knowledge of ICH/GCP guidelines and FDA regulations
• Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and when to seek support.
• Strong verbal and written communication skills
• Proficient with MS Office software

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

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.