The position will work directly with hospital, clinic and research staff in the development, implementation and management of clinical trials.  Responsible for the collection, coordination, processing, and quality control of clinical trial data in accordance with protocols subject to FDA oversight.  Responsible for coordination of long-term follow-up activities associated with these protocols.  Uses judgment in data collection, quality control, liaison, and research coordination activities.  Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/Seattle Children’s UW system including the Fred Hutch Transplant Service.  This individual will work under limited supervision of the Senior Clinical Research Manager and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.

This role will have the opportunity to work partially at our campus and remotely.

• Review and maintain familiarity with research protocols with regard to data collection.
• Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up.
• Evaluate patient eligibility for clinical trials and assist in screening and patient enrollment.
• Understand and interact with departments and automated systems throughout Fred Hutch/Seattle children’s/UW system to ensure timely and complete delivery of data.
• Track status of potential and active clinical trial participants.
• Manage long-term follow-up evaluations and data collection with clinical trial participants, Fred Hutch/Seattle children’s, and participants’ local physicians.
• Develop data acquisition forms and instructions for completion.
• Manage and work with computer application specialists to ensure consistency between paper and electronic data systems.
• Manage monitoring visits and quality control reviews by Sponsors or Investigators.
• Support regularly scheduled institutional monitoring visits by Sponsors or Investigators to ensure quality and completeness of data.
• Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements.
• Manage special projects regarding data collection, analysis, output, and presentation.
• Provide input to support policies and goals of the program. Manage submission of reports in conjunction with the PI and Sr. Clinical Research Manager to the Human Subjects Committee, Institutional Review Board, Radiation
• Safety Committee, Federal Drug Administration, Pharmaceutical Companies, and other agencies.
• Liaise with Institutional Review Boards (IRB’s) in submission of protocol, study amendments, annual reporting and adverse event reporting.
• Perform other responsibilities as required.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree in scientific/medical field or equivalent combination of education and experience.
• Six or more years of experience in medical records, cancer registry, clinical study coordination or related field.

PREFERRED QUALIFICATIONS:

• Preferred Advanced Degree (Master’s level or higher) in the scientific/medical field.
• Clinical Research Associate (CRA)/ Clinical Research Professional (CRP) certification is highly desirable.
• Strong computer skills, including proficiency in Excel and Word, and experience working with databases.
• Strong verbal and written communication skills.
• Knowledge of medical terminology.

The annual base salary range for this position is from $80,172 to $114,941, 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).