Good Clinical Practice (GCP) IT Auditor
Good Clinical Practice (GCP) IT Auditor
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Job Description
Cohesive Technologies is a global IT Services & Solutions company providing IT Staffing Services and Application Development Services necessary for technology leaders to deliver business value. We help our people and clients succeed by leveraging our expertise deep industry and market knowledge proprietary assessment tools and techniques and project delivery methodologies. Through relationships with thousands of specialized professionals we bring an unparalleled ability to match talent with opportunities by assessing recruiting developing and engaging the best and brightest people for our clients. We combine broad geographic presence world-class solutions and a tailored consultative approach to help our people and clients achieve higher performance and outstanding results.
Job Title: Good Clinical Practice (GCP) IT Auditor
Duration: 6 Months
Locations: Raleigh NC or King of Prussia PA (Onsite/Hybrid)
40% travel is included.
Position Overview:
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We are seeking a qualified and experienced GCP (Good Clinical Practice) Auditor to join our team. The ideal candidate will possess a strong background in clinical research regulatory compliance and GCP standards. As a freelance auditor you will be responsible for conducting independent assessments of clinical trials and research studies to ensure compliance with GCP guidelines applicable regulations and sponsor requirements.
Responsibilities:
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Perform comprehensive audits of clinical trial sites investigator sites contract research organizations (CROs) and other entities involved in clinical research.
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Review study protocols informed consent forms case report forms (CRFs) and other essential documents to assess compliance with GCP standards and regulatory requirements.
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Evaluate the conduct of clinical trials including subject recruitment eligibility criteria study procedures data collection and adverse event reporting.
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Verify the adequacy of site facilities equipment and personnel training to ensure the safety and integrity of study participants and data.
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Assess the quality and completeness of trial documentation including study records source documents and regulatory submissions.
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Identify deviations non-compliance issues and areas for improvement during audits and collaborate with stakeholders to develop corrective and preventive action plans.
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Prepare detailed audit reports documenting findings observations and recommendations for corrective actions and ensure timely follow-up to verify implementation.
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Stay informed about changes in GCP regulations industry guidelines and best practices and guide stakeholders on compliance requirements.
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Communicate effectively with study sponsors investigators study coordinators and other relevant personnel to facilitate audit activities and promote compliance awareness.
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Maintain confidentiality and integrity throughout the audit process adhering to ethical standards and professional conduct.
Requirements:
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Bachelors degree in life sciences pharmacy nursing or a related field. Advanced degree (e.g. masters or Ph.D.) preferred.
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Extensive experience in clinical research including a minimum of 5 years working in clinical trials management monitoring or auditing.
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In-depth knowledge of GCP regulations (e.g. ICH E6) FDA regulations and other relevant local guidelines governing clinical research.
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Proven experience conducting GCP audits either as an internal auditor sponsor representative or independent consultant.
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This position carries the possibility of occasional travel for audits.
Cohesive Technologies is an equal access/equal opportunity employer and does not discriminate on the basis of age color disability marital status national origin race religion sex sexual orientation veteran status or any other classification prescribed by applicable law.
Employment Type
Full-time
