Providence Health & Services Clinical Research Compliance Auditor in Renton, Washington
Providence St. Joseph Health is calling a Clinical Research Compliance Auditor to any of our Providence locations.
We are seeking a Clinical Research Compliance Auditor to conduct compliance auditing activities associated with clinical research studies that include but are not limited to the review of all research-related activities
and documents to assess and evaluate the compliance of those activities to internal policies, standards operating procedures (SOPs), and relevant regulatory requirements. The position will also conduct quality control auditing to verify that clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOPs, Good Clinical Practices, and relevant regulatory requirement. In this position, the incumbent will be responsible for developing and implementing a comprehensive clinical
research compliance auditing plan.
In this position you will have the following responsibilities:
Complete clinical research compliance audits to assess whether clinical research activities are in compliance with industry standards, Good Clinical Practices and relevant regulatory requirements
Investigate potential clinical research compliance issues.
Prepare and issue detailed audit reports to appropriate personnel outlining potential compliance issues noted during audits/inspections. Support preparation and deployment of associated corrective action plans as well as follow-up to assess progress and verify effectiveness of such plans
Assist in the preparation of responses to regulatory agencies requests when appropriate and conduct quality audits of the data sent to regulatory agencies as needed.
Required qualifications for this position include:
Bachelor's Degree in Health Sciences or equivalent education/experience
4 years of clinical research quality assurance, clinical research compliance, regulatory affairs, or clinical research/study coordination function
Advanced demonstrated written communication skills, strong verbal communication and listening skills, excellent organizational skills, and demonstrated time management and priority setting skills
Preferred qualifications for this position include:
Experience in managing data collection, reporting, outcomes, quality improvement, standards/pathways.
Direct experience in research operations.
Experience with audits.
Experience with compliance auditing.
Experience in meeting FDA (GCP, ICH guidelines), as well as other Federal, State and Local regulations for research administration.
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 St. Joseph health 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: Health Care
Other Location(s): Oregon-Beaverton, Alaska-Anchorage, Montana-Missoula, Oregon-Portland, California-Burbank, California-Irvine
Req ID: 231957