Description:
Delivering on the promise of medical innovation begins at Boston Scientific

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.



Purpose/Role Statement

The Sr. Clinical Compliance Specialist – GLP / GCP - will conduct system audits of sponsor, investigational site, and vendor audit responsibilities to verify compliance of clinical trials with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP), Boston Scientific Corporation SOPs, and applicable regulatory / FDA requirements.

Key Responsibilities
Responsible for scheduling, planning, conducting, and reporting audits of medical device clinical trials to assure compliance with corporate policies, procedures, GLP / GCP, and other applicable regulatory requirements. Must be able to work independently, lead and / or participate as part of an audit team.

1) Assess compliance of sponsor/investigator/monitor responsibilities to protocol, contracts, internal SOPs, GCP, and other applicable regulations.
2) Conduct system audits to verify the effectiveness of the clinical Quality System with minimal supervision.
3) Professionally communicate audit observations to Clinical, and Quality Management.
4) Serve as a consultant by providing guidance and meaningful interpretations of applicable regulations to clinical teams.
5) Assist in the continuous improvement and development of internal departmental SOPs, tools, and processes.
6) Assist in FDA regulatory inspections.
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Experience:
Qualifications
Experience: Minimum of 7+ years of clinical (GCP) auditing experience in the medical device, pharmaceuticals, CRO or comparable environment
Education: Bachelor's degree (B.A. or B.S.) in Life Sciences, Public Health, Nursing with relevant clinical research experience. A Masters degree in a relevant field or RN is a plus


Working Conditions*
General office environment, with significant domestic and international travel (40-50%) to other BSC facilities for auditing and or/meetings and conferences.

Competency Expectations:
• Comprehensive working knowledge of the clinical research process including the FDA Code of Federal Regulations (21 CFR Part 11, 50, 54, 56, 58, 312, 812, 820), ICH-GCP Guidelines, ISO 14155-1,2; familiarity with human anatomy, physiology, and medical terminology
• Excellent verbal / written communication, interpersonal, and organizational skills; must be able to multi-task, assimilate, and analyze information quickly.
• Computer skills required are MS Word, Excel, MS Outlook, and general database experience
• Willingness to be proactive, work independently, and as a contributing member of a dynamic, highly visible team