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The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) provides statistical collaboration to infectious disease researchers around the world and conducts a complementary program of statistical methodology, and mathematical modeling research. SCHARP also collects, manages, and analyzes data from clinical trials and epidemiological studies dedicated to the elimination of infectious disease as a threat to human health. Current projects include studies to evaluate and implement prevention strategies for HIV, tuberculosis, polio, malaria and other globally important pathogens
The Statistical Center for HIV/AIDS Research & Prevention (SCHARP) is looking for a Clinical Quality Assurance Specialist .
The Clinical Quality Assurance Specialist is a member of the quality team and provides quality support to ensure compliance with industry guidelines and regulations. This position reports to the Quality Assurance Manager.
As a quality team member:
- Implements, maintains, and monitors all aspects of the comprehensive quality program in support of clinical trial research.
- May lead quality activities.
- Provides guidance and assistance to SCHARP staff on various aspects of the quality program.
- Provides guidance to junior quality team members, as needed.
- Maintains and employs the document control system, including maintenance of internal procedures, contractual requirement documents and ensuring that document change requests and biennial reviews of documents are facilitated and implemented within a timely manner.
- Reviews internal procedures and other quality documents, as needed. May be tasked to develop or revise procedures and company documents.
- Maintains and implements the employee SOP training program and system, including providing new employee orientation, assigning training to staff members, maintaining the training matrix, training system, master training files and monitoring progress. May develop and facilitate quality related specialty training to administrative and technical staff, as identified by need.
- Implements and maintains the vendor/supplier/contractor qualification and audit program and system in coordination with Vendor Management and senior quality staff.
- Implements and maintains the internal audit program and system.
- Implements and maintains the deviation and corrective and preventative action (CAPA) program, including conducting root cause analysis, trending, monitoring and coordination of interdepartmental corrective action and preventive activities.
- Assists in the execution of client surveys.
- May facilitate internal and external presentations, when required.
- Ensures timely completion of deliverables and provides timely reports, were applicable.
- Keeps management and stake holders abreast of quality related activities.
- Maintains consistently high performance standards and quality of work.
- Adheres to internal SOPs and applicable regulatory requirements, as well as, encourages and ensures compliance among others.
- Implements improvement activities in collaboration with other departments.
- Attends, organizes and participates in meetings, as needed. May act as quality representative.
- Interacts strategically with cross-functional teams on projects and other activities.
- When assigned, assists SCHARP management, stake holders and senior quality team members in preparation of onsite audits/inspections and in facilitating corrective actions, as applicable. Assists in activities to prepare units, departments and personnel to be inspection ready.
- May participate in regulatory inspections, third party client audits, as assigned, including monitoring and implementing corrective action activities.
- May represent company at professional meetings and/or training.
- Performs other tasks as assigned by the Quality Assurance Manager, senior quality staff and/or SCHARP Senior Management.
- Please note this position is malleable and flexible to applicants at the Clinical QA Specialist I - IV level. Bachelor's degree with a minimum of 1 (I), 2 (II), 3 (III), 4 (IV) years of experience implementing elements of quality assurance and/or quality control in a regulated environment. 3 (I) 4 (II), 5 (III), 6+ (IV) years of progressive experience in implementing quality systems may substitute educational requirement.
- Must be detailed oriented with ability to maintain accurate digital and paper records.
- Strong organizational and multi-tasking skills are required, as are excellent verbal and written communication skills.
- Proficiency in MS Office applications is essential.
Experience with the following aspects of quality systems is strongly desired:
- Document control: developing procedures, maintaining and implementing a document control system (e.g., MasterControl)
- Internal auditing
- Vendor/supplier auditing
- Deviation and CAPA reporting
- Staff training: assigning and maintaining a training system, developing and facilitating training and presentations to technical and non-technical personnel
- Regulatory inspections and Third party client audits
- Quality metrics, trending
- Change control
- Support of system validations
- Document and archive management
- Continuous improvement efforts
- Client satisfaction efforts
- Compliance (internal procedures, contractual requirements and regulatory GxPs and guidelines for: GCP, ISO, CFRs, NIH and EU)
- Knowledge of applicable industry statistical and data management guidelines, best practices and requirements
- Specific training, certification, registration or professional designation in a GxP
- Requires ability to work in a team environment.
- Requires ability to work independently with occasional guidance from senior quality staff.
- Requires excellent interpersonal skills and excellent written and oral communication skills to explain concepts.
- Requires strong organizational skills and the ability to maintain accurate and detailed records.
- Requires ability to interact efficiently, cooperatively and professionally with all functional team members and other SCHARP staff.
- Requires the ability to exercise good judgment and the ability to prioritize activities.
- May require ability to lead project activities and ensure deliverables are met within an established time frame.
- May require occasional long hours, weekend or holiday hours, as needed to complete an important activity on schedule.
- May require ability to provide guidance to junior staff, as needed.
- May require the ability to facilitate formal and informal presentations and training in group settings.
- May require ability to travel on long or short term business trips.
- Requires ability to read, write and speak English.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2352622-2647-2921