Philadelphia, PA, 19133, USA
14 days ago
Clinical Research Auditor
Job Title: Clinical Research Auditor Job Description We are seeking a highly experienced Clinical Research Auditor with a minimum of 7 years of clinical research experience. The ideal candidate will have a deep understanding of human subjects clinical research and the principles of conducting compliance oversight. Responsibilities + Conduct thorough audits of clinical trials to ensure compliance with federal regulations, GCP, and IND/IDE. + Work closely with various departments to ensure adherence to regulatory affairs and quality control standards. + Maintain detailed records of audits and prepare comprehensive reports. + Collaborate with research teams to provide guidance on compliance issues. + Stay updated on the latest regulations and best practices in clinical research. Essential Skills + 7 years of clinical research experience as a monitor/auditor, research nurse, research coordinator, regulatory affairs, quality control, and assurance or compliance. + Strong understanding of human subjects clinical research. + In-depth knowledge of federal regulations, GCP, and IND/IDE in both adult and pediatric research. + Proficiency in MS Word and Excel. + Excellent organizational and time management skills. + Ability to handle confidential and sensitive data with discretion. + Ability to multi-task, prioritize, and pivot in a fast-paced environment. Additional Skills & Qualifications + Nursing degree (RN/BSN) or BSN/MSN. + Strong understanding of medical records/patient charts organization and terminology. + Detail-oriented and resourceful with mature judgment. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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