The Clinical Quality Auditor I assesses company activities to assure that contractual obligations to client companies are met, and determines whether clinical trials are conducted and reported in accordance with ICH Guidelines, regulatory requirements, and relevant PPD and client procedural documents.
Performs routine investigator site audits, study file audits, and study document reviews (e.g., Informed consent, CRF, source document templates). Work assignments include multiple therapeutic indications across different projects and clients. Also provides QA consulting advice to assigned PPD project teams, projects and external clients with guidance.ucation and Experience: Bachelor's degree in a life science field or equivalent qualification and relevant experienceMinimum of 1 year of clinical research experience in regulatory phase trials (e.g. CRA) with high level of competency orEquivalent combination of education and prior directly related experience Knowledge, Skills and Abilities: Successful completion of PPD Foundations TrainingFamiliar with ICH-Good Clinical Practices and appropriate regional clinical research regulations (e.g., FDA and other regulatory agency guidelines)Internal candidates must have a thorough working knowledge of PPD Clinical Standard Operating Procedures and Working Practice DocumentsExcellent oral and written communication skills (including appropriate use of medical and scientific terminology)Strong attention to detailAble to work independently or in a team environmentGood problem solving abilitiesGood organizational and time management skillsBasic computer skills and ability to learn and become proficient with appropriate softwareProven flexibility and adaptabilityValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for extensive business travelPPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member’s service.