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 Clinical Research Compliance Auditor will be responsible for auditing and compliance-related activities in support of the Monitoring and Compliance Programs. These programs provide oversight of clinical research activities and ensure participant safety. The position will report to the Clinical Research Support (CRS) Compliance Senior Manager and can be based in Seattle, WA or be remote.

Responsibilities

• Conduct visits to assess compliance with protocol requirements, applicable regulations, ICH/GCP, and institutional SOPs/policies.
• Conduct GCP audits, including preparation for sponsor audits and regulatory inspections.
• Review and verify accuracy and completeness of FDA submissions in relation to IND applications, as applicable.
• Assist investigators in protocol development. Review and edit protocols prior to implementation.
• Assess factors that might affect subject safety and clinical data integrity, such as protocol deviations, noncompliance and unanticipated problems, appropriateness and timeliness of adverse event reporting, and pharmacovigilance issues.
• Assist study teams with Corrective and Preventive Action (CAPA) Plan development and review.
• Advise CRS and Consortium Institutions on processes, guidelines, and best practices related to clinical research.
• Perform investigational product (IP) inventory accountability, including dispensation, storage, and security, and review subject-specific and regulatory documentation.
• Provide guidance to site staff regarding how best to address monitor's findings.
• Identify and escalate potential compliance risks (protocol and federal regulations) and identify retraining opportunities for site study teams.
• Develop internal processes for the CRS Compliance team (including auditing and monitoring), tools/templates, and standard operating procedures for the Consortium.
• Assist with development of CRS training activities.
• Prepare timely, appropriate, and accurate communication to study teams and central departments, including detailed final reports and associated documents.
• Participate in trainings to increase therapeutic knowledge and keep current with regulations and guidance.

Qualifications

• Bachelor's degree in a related field or equivalent combination of education and experience.
• Minimum of four (4) years of monitoring experience, including at least one (1) year of oncology monitoring experience OR a minimum of six (6) years as a research study team member with increasing responsibilities.
• Proficient operating knowledge of FDA regulations, ICH/GCP, and other regulatory requirements and guidance.
• Ability to work independently and maintain confidentiality.
• Excellent verbal and written communication skills, and the ability to communicate effectively with all levels.
• Knowledge of pharmaceutical industry, terminology, and practices
• Strong organizational skills and attention to accuracy and detail.
• Proficiency with Microsoft Office suite, electronic data capture systems, and other database programs.
• Ability to travel (less than 10%) and arrange travel schedule, including flights and hotel.

This position is patient facing and/or requires access to Fred Hutch clinical facilities. As such, full COVID-19 vaccination is required as a condition of employment, without exception. Booster doses are strongly recommended but not required. If declining a booster, completion of the COVID-19 Vaccination Status Form Questionnaire and COVID-19 Booster Declination Training is required. Because of our immunocompromised patient population, there are no medical or religious accommodations available for any employee who is patient facing and/or requires access to Fred Hutch clinical facilities. Only employees whose positions are fully remote, who are not patient facing and/or require no access to clinical facilities, may apply for medical or religious accommodations. As a condition of employment, newly hired employees must provide proof of vaccination before their first day of employment.

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 $81,979 to $122,969 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 hrops@fredhutch.org or by calling 206-667-4700.