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 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.
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 monitors the collection, processing, performs routine data entry and quality control of study data. The Sr CDC work within a network/study/protocol team to support the policies and goals of each project assigned. They develop and maintain successful working relationships with their team and specific research sites to ensure and maintain data integrity and quality.
The Sr CDC adheres to SCHARP Standard Operating Procedures (SOPs), Work Practice Guidelines (WPGs), applicable clinical trial regulations, and study confidentiality requirements.
The Sr Clinical Data Coordinator will work under the supervision and mentoring of Sr. Clinical Data Managers and departmental leadership. 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. Responsibilities may include some or all of the following:
Perform routine data entry including first and second pass validation as required.
Adhere to current data entry priorities using appropriate tools and resources.
Add and resolve QC notes to data fields.
Act as liaison for data management issues between SCHARP study teams and research sites.
Attend assigned SCHARP study team meetings and conference calls.
Assist in development of Case Report Forms for assigned studies.
Manage study data for assigned studies.
Assist in the maintenance of the study database including routine revisions or additions.
Monitor study data to insure the quality and completeness of the data submitted by implementing quality control procedures as appropriate per CDMS.
Generate QC reports for site review and correction as well as a variety of other reports as required.
Evaluate study data for protocol compliance.
Assist in production and review of Data Operations SOPs and WPGs.
Assist Data Operations staff in resolving non-routine data entry issues.
Perform additional tasks as appropriate and assigned.
Bachelor's degree or equivalent, preferably in a health-related or scientific discipline.
2+ years' experience in the pharmaceutical/clinical research environment as Clinical Data Coordinator or equivalent role.
EDC experience required. Working knowledge of Medidata Rave highly desirable.
Demonstrated expertise in relevant clinical data management activities.
Working knowledge of ICH/GCP guidelines and FDA regulations.
Familiarity with all phases of clinical trials and ability to adapt to study requirements.
Strong verbal and written communication skills. Ability to understand and follow instructions and guidelines; able to pick up new tasks quickly; willing to ask questions when a task is not fully clear.
Ability to exercise independent judgment within generally defined practices and policies. Shows good judgment in interpreting guidelines and in when to seek support.
Ability to work independently and to work efficiently under pressure.
Consistent, dedicated, versatile and able to prioritize and multi-task.
A strong team player with optimistic attitude.
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Fred Hutchinson Cancer Research Center