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Job #02841

About our client Our client is a leading drug company with close to $10B in sales and over 10,000 employees worldwide. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up to date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Compliance Specialist San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Apply knowledge of GCP regulations/guidelines to independently address a variety of complex issues related to drug development 2) Coordinate and assign audits 3) Perform assigned audits including internal system audits, external vendor audits and clinical investigator site audits 4) Review documents to be submitted to regulatory authorities 5) Identify compliance risks during audits and report findings to appropriate management with recommendations for resolution 6) Understand and evaluate clinical sites for compliance with the requirements for ICFs, CRFs and documents for the TMFs as well as RA files 7) Perform/review complex literature/database searches for additional or supporting compliance information (as appropriate) 8) Provide well-informed audit findings and recommend corrective/preventive actions 9) Develop compliance opinions and provide education or training to GCP functional areas 10) Research and write formal CCG compliance opinions or provide other verbal/written guidance on complex compliance issues 11) Develop specific audit plans 12) Lead, perform (independently) or train other auditors to perform complex compliance audits 13) Facilitate resolution of audit issues 14) Coordinate compliance projects 15) Provide training presentations in audit or regulatory trends, procedures for audit responses and other topics 16) Present GCP training (externally) at Investigator meetings 17) Provide compliance guidance to all audited parties to encourage process improvements 18) Serve as an internal consultant in interpretation of regulatory requirements and expectations Requirements 1) Bachelor’s degree in Science (MS, RN or Pharmacy degree preferred) 2) 7+ years of clinical research experience including 3+ years in GCP auditing 3) Highly skilled auditor with in-depth understanding of complex regulations, guidelines, quality systems and compliance issues 4) Knowledge of and ability to apply the FDA and ICH regulations and guidelines along with other applicable regulations and guidelines 5) Proficient as Lead Auditor and Trainer 6) Excellent presentation and communication (verbal and written) skills 7) Ability to assimilate new and emerging compliance information or trends 8) Ability to determine objectives and approaches to problem solving 9) Ability to influence and negotiate effective solutions