Clinical Trials Document Specialist Ii

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The candidate will be responsible for curating common data elements for various COMPASS projects and designing flow diagrams for eligibility/randomization algorithms. In addition, the Clinical Trials Document Specialist is responsible for the management and oversight of Trial Master File (TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with COMPASS’s SOPs and all applicable regulations. The Clinical Trials Document Specialist focuses on inspection readiness, monitors compliance of the TMF and supporting documents, and supports preparation of documentation required for regulatory agency inspections and internal audits. They oversee set-up and consolidation of elements of the TMF with support from the study team and perform periodic quality assessments of the TMF documents where required. The Clinical Trials Document Specialist will assist in the development of an overall clinical trials document archiving strategy. They will develop and maintain successful working relationships with the study teams and departments.

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

Responsibilities

• Work closely with IT team
• Facilitate the design and development of data collection forms, instructions and procedures.
• Ensure adequate set-up of trial master files including proper and timely filing of all relevant study documents.
• Ensure Study Personnel Lists, Staff Rosters, and Study Specific Training are documented in the TMF.
• Conduct TMF content reviews and provide TMF quality and content reports on a regular basis.
• Other duties as assigned.
• Assist department study leads with uploading, archiving, and managing documents within the eTMF and help study team members resolve issues.
• Provide TMF support and management of electronic TMF records across functional areas, and management of electronic TMF records for assigned clinical trials.
• Develop, implement, and maintain an overall archiving strategy for documents and files both within and external to the Trial Master File (TMF).
• Participate in organizational process improvements as required.
• Promote, monitor and help ensure the quality, completeness, and overall inspection readiness of the TMFs study documentation for all functional areas.
• Serve as the electronic TMF system Subject Matter Expert and work closely with the IT Manager and Project Manager to support the electronic TMF system.
• Assist in the development of SOPs and other relevant documents associated with the TMF.
• Review and understand research protocols and eligibility criteria
• Develop and maintain flow diagrams developed to document coding processes around eligibility and randomization.
• Conduct data harmonization
• Assist in internal trial master file audits to ensure compliance with applicable work instructions, SOPs, and regulatory guidelines.

Qualifications

Minimum Qualifications:

• Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practices pertaining to clinical trial document management and archiving
• Bachelor’s degree or its international equivalent in Computer Science, Health Sciences, Information Management or related field or the equivalent of relevant experience
• Experience working with clinical electronic databases, preferably Medidata Rave
• Minimum 3 years of document management experience.

Preferred Qualifications

• 5+ years of document management experience
• Master’s degree or its international equivalent in Computer Science, Health Sciences, Public Health, Information Management or related field or the equivalent of relevant experience
• Experience in organizing documents for internal and external audits

As a Condition Of Employment, Newly Hired Employees Must, Prior To Their First Day Of Employment

Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.

Provide proof of being fully vaccinated against COVID-19 ; OR

Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).

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

The annual base salary range for this position is from $70,817 to $106,225, and pay offered will be based on experience and qualifications.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity

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 [email protected] or by calling 206-667-4700.