Providence Health & Services Research Quality Assurance (QA) Specialist in Seattle, Washington
Providence St. Joseph Health is calling Research Quality Assurance (QA) Specialist to our location in Seattle, WA.
We are seeking a Research Quality Assurance (QA) Specialist to coordinate and manage QA activities associated with industry sponsored, and investigator initiated clinical research studies that include, but are not limited to, the review of all trial-related activities and documents to assure compliance with the investigational plan, internal policies/processes, standard operating procedures (SOPs), Code of Federal Regulations (CFRs), Good Clinical Practices (GCPs) and all other relevant guidance and regulations. The QA Specialist will work closely with research leadership, staff, sponsors and investigators to address compliance challenges and issues. In this position, the incumbent will be responsible for working with research leadership to develop and implement a comprehensive quality assurance program in the context of clinical trials management. He/she will build a culture of excellence and compliance with the goal of achieving an audit-ready operation at all times.
In this position you will have the following responsibilities:
Responsible for the completion of internal quality assurance audits and monitoring activities for clinical trials conducted or supported by the Swedish Center for Research and Innovation.
Review research protocols and subject and/or study logs to assess study requirements for participants.
Review patient eligibility for enrollment into trials to ensure compliance with protocol.
Review consent forms to assess whether proper guidelines were followed for Human Subject consent.
Review source documents and case report forms to assess whether study visits occurred within protocol-defined study windows; reviews source documents and case report forms to determine whether protocol-required or recommended procedures were completed during study visits.
Review whether Adverse Events and Serious Adverse Events were thoroughly and accurately reported according to regulatory requirements.
Review materials provided to study participants to assess for compliance to Human Subjects regulations
Contribute to the development and maintenance of tracking tools to log audit results including areas of non-compliance and informing what areas of improvement are needed for discussion with management. Utilize research audit tools that assess the quality indicators.
Coordinate post-audit activities and follow-up on any necessary corrective and preventive actions; resolve any conflicts. Report deficiencies to Managers and other appropriate personnel.
Maintain accurate records of findings of analysis of compliance; contribute in the preparation and implementation of corrective action plans; audit response timelines and escalation plans; communicate expectations in a collaborative environment.
Participate in and helps facilitate audits conducted by external agencies (i.e., Sponsor, FDA inspections).
Review outcomes from monitoring visits and tracks non-compliance events.
In coordination with department management helps develop, implement and maintain policies/procedures, systems and standard operating procedures which support conduct of clinical trials at the Swedish Center for Research and Innovation.
Conduct and/or participates in audit wrap-up meetings.
Define compliance and quality metrics, performs qualitative and quantitative data analyses and reports findings to management.
May be involved in identifying and developing continuous improvement efforts. This includes identifying opportunities for improvement, problem prioritization, and assisting in the creation of performance improvement plans for non-compliant audits and/or reports.
Work collaboratively with the Swedish Center of Research and Innovation administration, Investigators, external sponsors to develop and implement quality assurance plans in support of clinical trials.
Assist with the development and implementation of quality assurance assessment materials (e.g. audit plans) aimed at monitoring compliance to trial enrollments with regard to the protocol plan, applicable regulations, policies, and procedures.
Report and follow-up on audit findings and corrective actions as applicable to assure that clinical trials research processes, procedures and activities are in compliance with industry standards, GCPs and other current Regulations and Guidance.
Identify areas of deficiency in quality and report those to managers and other appropriate personnel.
Maintain confidentiality of all information related to patients, medical staff, employees, and as appropriate, other information.
Demonstrate service, excellence and positive interpersonal relations in dealing with others, including co-workers, colleagues, managers, sponsors and medical staff so that productivity and positive relations are maximized.
Develop individual objectives consistent with the goals of Swedish Center of Research and Innovation and report on individual objectives on a regular basis.
Required qualifications for this position include:
Bachelor's Degree in Science, Healthcare, or other related field OR equivalent education/experience.
Three (3) years relevant experience in research quality assurance, regulatory affairs, or clinical research/study coordination function required. Significant education in the field of clinical research, regulatory affairs or compliance can be substituted for experience.
Strong understanding of clinical research conduct, knowledge of investigational therapies in multiple therapeutic areas.
ACRP, SoCRA or HCCA certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research) is required within the first year of employment.
Preferred qualifications for this position include:
- Reviewing/verifying the timely accurate submission of clinical trial data, reporting findings and proposing improvements.
About the department you will serve.
Providence Strategic and Management Services provides a variety of functional and system support services for all eight regions of Providence Health & Services from Alaska to California. We are focused on supporting our Mission by delivering a robust foundation of services and sharing of specialized expertise.
We offer a full comprehensive range of benefits - see our website for details
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence Health & Services is a not-for-profit Catholic network of hospitals, care centers, health plans, physicians, clinics, home health care and services guided by a Mission of caring the Sisters of Providence began over 160 years ago. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Quality/Risk/Safety (Non-Clinical)
Req ID: 256382