Providence Health & Services.
Everett, WA, United States
Compliance, Clinical Research, Research, Sciences
Regulatory Compliance Analyst','210517','Full-time','Day','Healthcare Practitioner and Technician','Washington-Everett','','!*!
Providence is calling a Regulatory Compliance Analyst (1.0 FTE, Days) to Providence Regional Medical Center Everett in Everett, WA.
We are seeking a Regulatory Compliance Analyst that is responsible to prepare, facilitate, coordinate and submit documentation required by federal state and local regulations and institutional requirements relating to the conduct of research.
In this position you will:
Prepare and/or present applications for initial submission to Institutional Review Board (IRB) for review including complete required application forms, create consent forms to meet SMC standards, collect appropriate supporting documents.
Prepare applications for ongoing annual review by IRB including: completion of required annual report form, updated consent form, collection of information regarding results of study or findings to date, adverse events experienced, etc.
Submit Safety Adverse Event (SAE) reports to IRB as required by sponsors and, if needed make changes to consent form to reflect new information about adverse events; provide support to internal/external staff in completing SAE reports for submission to study sponsors and the IRB.
Analyze and revise the process for meeting compliance issues in preparation for internal and external audits. ','!*!
Required qualifications for this position include:
High School diploma or equivalent.
Minimum of two (2) years of experience in clinical research and regulatory affairs.
Working knowledge of FDA regulations and GCP guidelines.
Preferred qualifications for this position include:
About the hospital you will serve.
Providence Regional Medical Center Everett in Everett, WA is the state’s most award-winning hospital for medical care; having received the HealthGrades Distinguished Hospital Award for Clinical Excellence four years in a row. Our new state-of-the-art 12 story hospital tower and the implementation of Epic electronic medical records system will significantly enhance our patient’s experience throughout the continuum of care.
The hospital is located in Snohomish County on the Sound and close to the mountains, so outdoor activities such as snow skiing, kayaking, and golfing are at your doorstep. The communities in Snohomish have all the comforts and appeal of small towns, with historical districts, beautiful homes, interesting boutiques, and unique restaurants, yet the city life of Seattle and Bellevue are just 30 minutes south, while the cosmopolitan city of Vancouver, BC lies only 2 hours north. ','!*!http://www.providenceiscalling.jobs/rewards-benefits','!*!http://www.providenceiscalling.jobs/rewards-benefits','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.','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 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.','Regulatory Compliance Analyst
Providence Health & Services.
Website : http://www.providence.org
About Providence Health & Services Creating Healthier Communities, Together As the third largest not-for-profit health system in the United States, we are committed to providing for the needs of our communities – especially for those who are poor and vulnerable – across Alaska, California, Montana, Oregon and Washington.