Provide GCP and compliance-related audits of internal and external Clinical Studies in process
Support updates of procedures in compliance with applicable regulations
Perform vendor audits as needed
Act as a Clinical Quality Auditor Lead on clinical trials by supporting project team compliance with national and international regulatory standards and guidance for medical devices
Support development of audit management plans and audit strategy for ongoing clinical trials
Conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines and in alignment with internal audit plans
Participate in the development of departmental standard operating procedures, work instructions, forms, and templates
Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented/documented
Support or conduct training for staff (GCP, Inspection Readiness training, etc.)
Support regulatory inspections
Review/revise Standard Operating Procedure (SOPs) and procedures as assigned
Responsible for initial and ongoing audit of clinical study vendors such as CRO, imaging core lab, central laboratory and other vendors as needed
Identify and escalate site, vendor and study related issues to management, as appropriate

Bachelor’s Degree or equivalent experience in a scientific field of study
5 years’ experience directly supporting clinical research, QA, or relevant experience in medical/scientific area
Experience conducting audits of vendors and investigative sites
Experience interacting with regulatory authority inspectors
Experience preparing and supporting clinical study sites undergoing regulatory authority inspections
Experience revising SOPs and procedures
Thorough knowledge and application of Good Clinical Practice (GCP) is required, i.e. FDA, ISO 14155, MDR
Medical Device experience is preferred
Ability to travel up to 30%-40% of time domestically and internationally
Basic understanding of peripheral and coronary artery disease and therapies preferred
Knowledge and experience in supporting device pre
and/or post-market clinical studies is required
ACRP or SOCRA certification preferred

Eligible for company’s consolidated retirement plan (pension) and savings plan (401(k))
Participation in company’s long-term incentive program
Vacation – 120 hours per calendar year
Sick time
40 hours per calendar year
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Senior Clinical Quality Auditor – Shockwave Medical

Key skills