Job Title:
Sr. Clinical Quality Specialist

Req #:
4465BR

Job Description:
Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for conducting internal and external audits.

Job Duties:
Conduct external and internal comprehensive audits and document reviews independently and effectively in compliance with department SOPs. During audits, gather information and evaluate processes against applicable regulations (FDA, HIPAA, etc.), SOPs and policies, company business needs and other applicable standards. Distinguish between relevant and irrelevant facts to provide accurate and timely audit reports with recommendations for resolution; follow all major and critical findings to completion of resolution. Support department training and SOP development needs. Support department management when hosting FDA inspections.

Qualifications


Education:
Bachelor's degree preferably in biological or medical sciences. Experience: Five years experience in a compliance, regulatory or clinical environment, preferably with at least 2 years Good Clinical Practices audit experience.

Special Skills:
Expert organizational, written and verbal communication skills and the ability to present with a professional and diplomatic approach are required for this role. Specialized Training: Extensive knowledge of GCP regulations/guidelines and Privacy regulations worldwide, as they pertain to clinical research and a good understanding of drug and device clinical trial development processes and clinical monitoring practices.

Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes

Status Full-Time