Providence Health & Services Clinical Research Compliance Auditor in Irvine, California
Providence is calling a Clinical Research Compliance Auditor. This role can sit in Providence Southgate II in Renton, WA or the System Office in Irvine, CA.
In this position you will have the following responsibilities:
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 (SOP's), and relevant regulatory requirements.
Conduct quality control auditing to verify that clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOP's, Good Clinical Practices, and relevant regulatory requirement.
Be responsible for developing and implementing a comprehensive clinical research compliance auditing plan.
Required qualifications for this position include:
Bachelor's degree in health sciences -or- equivalent education/experience
4 years of experience in clinical research quality assurance, clinical research compliance, regulatory affairs, or clinical research/study coordination function
Ability to perform work independently with minimal supervision
Demonstrated time management and priority setting skills
Experience in managing data collection, reporting, outcomes, quality improvement, and standards/pathways
Experience with compliance auditing
Experience in meeting FDA (GCP, ICH guidelines), as well as other federal, state, and local regulations for research administration
Strong interpersonal skills and ability to interface with institutional faculty, administrators, and regulatory agencies
Ability to be flexible, multitask, and switch priorities as well as work comfortably in a deadline driven environment
Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously
Thoroughly familiar with Good Clinical Practices and procedures, and practices in a clinical research setting
Strong organizational, negotiation, interpersonal, verbal and written communication skills, and attention to detail
Experience working with pharmaceutical and FDA agency representatives
Demonstrated communication, leadership, and team building skills; evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others
Demonstrated skill in working with minimal supervision
Effective presentation skills
Working knowledge of Microsoft Office programs (Word, Excel, Access, and PowerPoint), email and internet
Experience with relational databases
Preferred qualifications for this position include:
- Certification in Healthcare Research Compliance (CHRC)
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 people of Providence, we reveal God's love for all, especially the poor and vulnerable, through our compassionate service.
Providence Health & Services is the third largest not-for-profit health system in the United States. Providence employs more than 82,000 caregivers (employees) across a five-state area; AK, WA, MT, OR, and CA. Our facilities include 34 hospitals, 600 physician clinics, senior services, supportive housing and other health and educational services. 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: Audit / Legal / Risk
Other Location(s): California-Burbank, Oregon-Beaverton, California-Irvine
Req ID: 163295