Clinical Research Quality Assurance Associate

Details: We are recruiting for a Quality Assurance Associate for Pharmaceutical Clinical Trial company located in Orlando Florida. ** Must have experience Auditing Clinical Trials** Qualified candidates would need to have a Bachelor's degree in life sciences, nursing or any other relevant discipline. Candidates will also need to have a minimum of 4 years of QA experience in the pharmaceutical research industry and an in-depth knowledge of U.S. and international standards and guidelines for the conduct and oversight of clinical trials. Primary Responsibilities:  Supervises and performs routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, process, system, study project and document reviews  Analyze and evaluate available data and prepare written audit reports of findings and observations to be shared with facilities and senior management as required.  Provides timely reports to QA Management up to date with findings and follow up on corrective/preventive actions.  Assist with oversight, development, and provide input for the development of clinical SOPs.  Assist developing strategies and policies for the quality program to improve department efficiencies and consistency, and for facilitating feedback to enable operations to take more proactive approaches.  Assist in the hosting of sponsor representatives (monitors, auditors, etc.), IRB personnel and regulatory (e.g. FDA, EMA, OSHA, DHHS, etc.) inspectors, as necessary.  Track and manage documentation regarding regulatory, sponsor and third party regulatory audits.  Provide guidance to operations staff with respect to ICH and applicable federal regulations.  Provide input and support as required to operations to ensure compliance to SOPs, GCP and other relevant Good Regulated Practice (GXP) requirements.  Maintain tracking of status of audits and projects, workload, initiatives and strategies, etc. of quality management activities.  Tracks and maintains quality event/incident reports such as Root Cause Analysis and CAPAs.  Supports and actively promotes the organization's mission and values.  Execute other duties as may be required by the Director and/or Vice- President, Quality Assurance as training and experience allow. Knowledge, Skills, and Abilities  Proficient and up-to-date with existing and emerging regulatory requirements pertaining to pharmaceutical human clinical research and an ability to communicate the philosophy and rationale that support these regulations.  Well developed analytical and problem solving skills.  Highly organized and able to multi-task.  Excellent organizational, interpersonal and customer service skills.  Proficient in MS Office Suite (Word, Excel, PowerPoint). Prerequisites:  Minimum four (4) years of QA experience in the pharmaceutical clinical research industry (GCP-focused; GLP a plus)  An in-depth knowledge of U.S. and international standards and guidelines for the conduct and oversight of clinical trials is required  Familiarity and experience with computer validation requirements and Part 11 is preferred If you are interested in being considered, please send your resume or contact Kimberly at 407.226.1554 for more information.
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