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.
The Clinical Research Compliance Manager is responsible for ensuring clinical research is conducted according to the highest quality standards and in compliance with local, state and federal regulations. The Compliance Manager reports to the Assistant Director of Regulatory Affairs and Compliance in the clinical trials office, Clinical Research Support (CRS), for the Fred Hutch/University of Washington Cancer Consortium. The position collaborates with partner institutions, Office of General Counsel, Institutional Review Office, Division Administrators, Clinical Research Management and Training.
Please include a cover letter with your application detailing your interest and qualifications for thisposition .
Prepares and implements remediation and corrective action plans, audits response timelines and escalation plans; communicates expectations in a collaborative environment
Conducts for-cause and spot audits of clinical trials
Develops, implements and maintains Compliance policies and standard operating procedures
Assesses resources and needs to meet NCI-Designated Cancer Center guidelines and Center strategic planning goals
Acts as primary Institutional contact for compliance and regulatory-related communications with outside sponsors, partners and regulatory institutions
Participates in Consortium study review committees
Coordinates with Regulatory Affairs team when needed to address regulatory-related matters
Defines compliance and quality metrics, performs qualitative and quantitative data analyses and reports findings to senior management
Assists with the development of standard training requirements and assists with ongoing compliance-related education and training for investigators and research personnel
Identifies compliance risks during study start-up and management; works directly with investigator and research personnel to define root causes and recommend areas of training and process improvements
Collaborates with partner institutions to facilitate start-up, management and audit of clinical research activities that are compliant with guidelines and regulatory requirements including billing compliance
Maintains visibility and awareness of the roles and resources available; represents the Program at presentations, meetings and other out-reach activities for Cancer Consortium faculty and research personnel
Participates in Center-wide and Cancer Consortium process improvement projects and leads quality-related improvement projects
Three to Five (3-5) years professional experience in clinical research
Significant experience in monitoring and auditing clinical research trials and internal processes
Strong experience with reading and editing protocols to assess/mitigate risk
Experience in root cause analysis and developing corrective and preventive action (CAPA) plans
Develop and maintain strong working relationships with cross-functional partners to provide coaching and compliance guidance as needed
Expert knowledge of regulations overseeing clinical trials including: 21CFR: parts 50, 312 and 812, 45 CFR part 46, ICH GCP E6(R2)
Aptitude for designing clinical research management tools that are applicable to a large audience
Experience in SOP development, editing, and management
Masters Degree in health care related field preferred
Experience working across large academic institutions
Clinical research certification preferred
Oncology and/or hematology research experience preferred
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 firstname.lastname@example.org or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.