Job Description

Responsibilities

Lead/manage Good Clinical Practice (GCP) audits, including clinical investigative site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs)
Serve as a QA representative and support clinical study teams to provide compliance advice
Participate in review and approval of clinical study documents and clinical SOPs / Guidance Documents
Manage study-specific Clinical Study Audit Plans (CSAP) compliance for the assigned program by using a risk-based approach for clinical studies
Review and approve investigational product (IP) temperature excursions to ensure release or rejection of IP on time
Lead continuous improvement of the Clinical Quality Management Systems (CQMS) and processes, including creation and revision of SOPs for GCP compliance and excellence
Manage and support inspection readiness activities for GCP
Support clinical inspections conducted by regulatory agencies, including sponsor inspections, clinical investigative site inspections, and contract research organization (CRO) inspections
Support GMP, GLP, and PV inspections
Lead clinical non-compliance event investigations and CAPA implementation
Perform quality metric analysis for clinical QA including study quality event trends from clinical process deviations / CAPAs to include a review of protocol deviations, safety, and other clinical data
Maintain a contemporary knowledge of agency and industry trends, standards, and methodologies as related to GCPs. Maintain the GCP regulatory surveillance program
Provide cross-training development opportunities to QA team members, and mentor/coach junior QA team members upon request or as an assigned supervisor

Preferred Education & Experience

BA/BS degree in a relevant field, or equivalent experience
6+ years’ clinical research experience
Understanding of Quality Systems that support GCP quality activities
Experience with advanced Microsoft Office applications (Word, Excel, PowerPoint)
Experience developing GCP processes for the best industry practices and training

Job Tags

Contract work, Work at office,

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