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Project Coordinator - GCP experience

Job Description

Must have GCP experience to be considered.


Oversee the planning, implementation, and tracking of individual GxP client projects which have beginning, ending, and specified deliverables. This job requires the ability to manage multiple tasks within each of multiple projects.


1. Achieve study objectives by working with team members to set project priorities and milestones and resolve project conflicts


2. Develop, track, and notify appropriate parties of study timelines, budgeted vs. actual hours, and quality metrics


3. Manage auditing projects from conception through final audit report completion/CAPA resolution


4. Proactively identify and resolve issues, and participate in process improvement initiatives as required


5. Respond promptly and appropriately to study questions and issues raised by clients, vendors, consultants, etc.


6. Perform other duties as assigned


Skills:


3-5 years planning and/or project management experience


1-3 years direct experience/knowledge of GCPs


Knowledge of project management, corresponding software to track work flow, and of the compliance auditing process


Communicate effectively


Creativity/innovation


Make decisions and implement solutions


Ability to work with minimal oversight


 


Education:


University degree or relevant, applicable work experience



Company Description
We are a highly specialized, independent, third party provider of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), PV (pharmacovigilance/drug safety), Good Distribution Practices (GDP), REMS (Risk Evaluation and Migitation Strategy) and Good Tissue Practices (GTP) auditing and consulting.
Quality assurance auditing, specifically in clinical and laboratory practices and critical path manufacturing processes, is essential to achieving 100% compliance during development from Preclinical to Phase IV through commercialization. The ClinAudits team of subject matter experts provides best practices to help you confidently and effectively accomplish your objectives.
As a global, independent and unbiased third party consultant, ClinAudits has unsurpassed auditing credentials. ClinAudits operates within the regulations and guidelines set forth by the FDA and other governmental authorities whose role is to ensure that products authorized for marketing have been produced to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety.



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