Clinical Research Support Quality Associate

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

The Quality Program Manager is responsible for developing, implementing and managing a comprehensive Quality and Compliance Program to ensure clinical research is conducted according to the highest quality standards and in compliance with local, state and federal regulations. This position reports to the Quality and Compliance Manager in Clinical Research Support (CRS) and collaborates with partner institutions, Office of General Counsel, Institutional Review Office, Division Administrators, Clinical Research Management and Training.

- Develops, implements and maintains Quality Assurance and Compliance policies, systems and standard operating procedures
- Assesses Program resources and needs to meet NCI-Designated Cancer Center guidelines and Center strategic planning goals
- Prepares and implements remediation and corrective action plans, audits response timelines and escalation plans; communicates expectations in a collaborative environment
- Coordinates with Regulatory Affairs team when needed to address regulatory-related quality and compliance matters.
- Acts as primary Institutional contact for compliance and regulatory-related communications with outside sponsors, partners and regulatory institutions
- Participates in Consortium study review committees
- Defines Program and Center 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 through the Quality Program; 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

Required Experience and Abilities
- 3-5 years working in an academic clinical research setting, preferably with study coordination experience
- Designing and administering quality assurance systems, clinical and financial aspects of research preferred
- Assessing risk in the conduct of clinical research
- Communicating with all levels of a research organization
- Interpreting federal regulations and guidelines
- Designing tools for the management of clinical research
- Developing corrective action plans for study teams
- Working across large academic institutions

Required Knowledge and Skills
- Bachelor's Degree
- Master's Degree in healthcare related field preferred
- Clinical research and compliance certification preferred
- Thorough understanding of the regulations governing human subjects research
- Excellent communication and negotiation skills
- Ability to perform systems analysis and process improvement
- Knowledge of clinical research monitoring processes and reports
- Strong written and verbal communication skills
- Ability to work collaboratively and build relationships across large organizations

We are a VEVRAA Federal Contractor

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2215078-2647-4721

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