The Emmes Corporation, founded in 1977, is a successful contract research organization based in Rockville, Maryland, dedicated to the support of medical research with a public health impact. Emmes is seeking a GCP Clinical Junior Auditor in our Rockville, MD office to support all phases of clinical trials.
The GCP Clinical Junior Auditor will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of Emmes projects, department, processes, and vendors used to support clinical trials. This individual will work closely with the QA Specialist and the QA Manager in support of Emmes’ corporate Quality Assurance Department.
Work closely with the QA Associate and the Quality Management Representative in support of Emmes's corporate Quality Assurance Department
Support / lead quality and standardization initiatives
Conducts audits to identify non-compliance to SOPs, regulations, and GCPs
Review Quality Records for accuracy and compliance (Compliance with SOPs, training records, test plans/scripts, CAPAs, audit reports)
Support regulatory/client audits
Assist in preparation of Quality Management Reports
BS degree and at least 1 year of experience in clinical trial auditing and quality assurance
Certified Quality Auditor, ISO, CCRA, or equivalent certification preferred
Knowledge and experience in the application of good clinical practice (GCP) requirements is required (eg, ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies
Experience in GCP auditing activities
Thorough knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines
Strong written and oral communication skills
Ability to work with others as well as independently
Ability to multi-task
Excellent organizational skills
Enjoy working in a team environment
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
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Emmes is proud to be an Equal Opportunity Employer EOE/M/F/D/V
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.