Employment agency specializing in Information Technology, Life Sciences and Finance recruiting, permanent and consulting services.
GCP Auditor (6-12 month contract role)
Plan and conduct GCP audits of clinical trials, vendors and internal documents and processes. Issues audit reports, recommends corrective action. Acts as Clinical QA project liaison. Keeps management informed of compliance status. Prepares company and clinical sites for regulatory inspections. Participates on inspection team. Reviews and recommends compliance related policies/procedures; provides training when necessary. Evaluates impending regulations, guidelines and industry standards and their impact on the clinical trials and the company.
Responsibilities:
-Plans and conducts GCP audits, as either lead or co-auditor.
-Audits may include clinical sites, vendors and internal document and process audits.
-Issues audit reports, recommends corrective action and may conduct follow-up to audits and corrective actions.
-Provides timely written reports to inform management of company's regulatory compliance status.
-Acts as Clinical QA project liaison.
-Prepares company and clinical sites for regulatory inspections; participates on inspection team.
-Participates in clinical trial product complaint management system.
-Performs GCP training.
-May train and mentor junior level auditors.
-Assists with development of Clinical QA SOPs, compliance tracking tools and audit worksheets.
Requirements:
-Bachelor's degree in the Life Sciences or equivalent is required. MS in the medical field (Nursing or Pharmacist) preferred.
5 years of in the pharmaceutical industry with 3+ years of prior experience in clinical compliance, quality assurance, and/or management of defined projects and staffs.
-Ability to prioritize work, manage multiple projects while maintaining quality in a fast paced environment.
-Basic Computer Skills: MS Word, MS Excel, MS PowerPoint, Adobe Acrobat.
-Strong understanding of GCP, FDA, ICH and European guidelines and regulations are a must.
-General knowledge of clinical activities, medical practice/techniques and terminology
-Demonstrated ability to work effectively with various groups to assure conformance to regulatory requirements, internal processes, and policies.
-Excellent verbal and written communication skills are a must.
-Previous monitoring experience is preferred but not required.
-Demonstrates a thorough knowledge of GCP regulations and guidelines.
-Ability to effectively manage multiple projects.
-Ability to effect change within an organization.
-Willingness to travel approximately 35% both domestically and internationally.
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