Good Clinical Practice (Google Cloud Platform) IT Auditor / Raleigh, NC or King of Prussia, PA

Overview

On Site
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 6 month(s)+

Skills

risk assessment
regulatory compliance
GCP Auditor
Clinical Research Auditor
IT Auditor (Clinical Research / GCP)
Compliance Auditor Clinical Trials
Good Clinical Practice (GCP)
ICH E6 Guidelines
FDA Regulations
Clinical Research Compliance
Clinical Trial Monitoring
Clinical Trial Audit
Audit Report Writing
Data Integrity & Patient Safety
Audit Planning & Execution
CRO Audits
Investigator Site Files
Site Audits
Compliance Reporting
Quality Management System (QMS)

Job Details

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 (Google Cloud Platform) IT Auditor

Duration: 6 Months+

Locations: Raleigh, NC or King of Prussia, PA (Onsite/Hybrid)

40% travel is included.

Position Overview:

  • We are seeking a qualified and experienced Google Cloud Platform (Good Clinical Practice) Auditor to join our team. The ideal candidate will possess a strong background in clinical research, regulatory compliance, and Google Cloud Platform standards. As a freelance auditor, you will be responsible for conducting independent assessments of clinical trials and research studies to ensure compliance with Google Cloud Platform guidelines, applicable regulations, and sponsor requirements.

Responsibilities:

  • Perform comprehensive audits of clinical trial sites, investigator sites, contract research organizations (CROs), and other entities involved in clinical research.

  • Review study protocols, informed consent forms, case report forms (CRFs), and other essential documents to assess compliance with Google Cloud Platform standards and regulatory requirements.

  • Evaluate the conduct of clinical trials, including subject recruitment, eligibility criteria, study procedures, data collection, and adverse event reporting.

  • Verify the adequacy of site facilities, equipment, and personnel training to ensure the safety and integrity of study participants and data.

  • Assess the quality and completeness of trial documentation, including study records, source documents, and regulatory submissions.

  • Identify deviations, non-compliance issues, and areas for improvement during audits, and collaborate with stakeholders to develop corrective and preventive action plans.

  • Prepare detailed audit reports documenting findings, observations, and recommendations for corrective actions, and ensure timely follow-up to verify implementation.

  • Stay informed about changes in Google Cloud Platform regulations, industry guidelines, and best practices, and guide stakeholders on compliance requirements.

  • Communicate effectively with study sponsors, investigators, study coordinators, and other relevant personnel to facilitate audit activities and promote compliance awareness.

  • Maintain confidentiality and integrity throughout the audit process, adhering to ethical standards and professional conduct.

Requirements:

  • Bachelor's degree in life sciences, pharmacy, nursing, or a related field. Advanced degree (e.g., master's or Ph.D.) preferred.

  • Extensive experience in clinical research, including a minimum of 5 years working in clinical trials management, monitoring, or auditing.

  • In-depth knowledge of Google Cloud Platform regulations (e.g., ICH E6), FDA regulations, and other relevant local guidelines governing clinical research.

  • Proven experience conducting Google Cloud Platform audits, either as an internal auditor, sponsor representative, or independent consultant.

  • 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.

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