- AbbVie (North Chicago, IL)
- …procedures in place to support the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's ... guidelines, policies and procedures. + Plan, organize and lead multiple GCP vendor compliance audits on a global scale. + Initiate, manage, and participate… more
- GE HealthCare (Boston, MA)
- **Job Description Summary** The Good Clinical Practice ( GCP ) Senior Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted ... ethically, with integrity, and in compliance with regulatory requirements and GCP guidelines. This role is responsible for providing QA auditing for the PDx… more
- Philips (Orange, OH)
- The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with ... + Planning, coordinating, and executing clinical audits to assess clinical study compliance with Good Clinical Practice ( GCP ), regulatory standards, and study… more
- Pfizer (New York, NY)
- …and help patients across the globe. **How You Will Achieve It** **ROLE SUMMARY** The Senior Manager, Auditor is responsible for the delivery and execution of the ... consumers, as well as data privacy and security. **ROLE RESPONSIBILITIES** + Assesses compliance of Vendors against applicable government agency GCP and GCLP… more
- Pfizer (New York, NY)
- …risks and non- compliance associated with Pfizer's GxP regulated operations. The Senior Manager Auditor , is responsible for the delivery and execution of the ... audit activities on assigned GxP enterprise processes that span GCP , PV, Regulatory, Medical or are conducted at the...is responsible for GxP Oversight and for assuring the compliance of projects, products and programs with Pfizer Standard… more
- ICON Clinical Research (Brentwood, TN)
- …the friendliest people in the sector, and you'll be helping shape an industry. ** Senior Auditor , QA- Can be remote** Recognize, exemplify and adhere to ICON's ... * Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to...Have a thorough knowledge of all relevant SOPs, with ICH- GCP and relevant regulations and guidelines. * Understand key… more
- IQVIA (Durham, NC)
- We are seeking a **Quality Assurance Auditor 2** to join Q2 Solutions, IQVIA's laboratory business in Durham, NC. We hire passionate innovators who drive healthcare ... as we transform and accelerate research and development. As a Quality Assurance Auditor 2, you will plan, conduct, and report assigned quality assurance audits,… more
- University of Pennsylvania (Philadelphia, PA)
- …as well as assisting with corrective actions and training related to research compliance , quality control and quality assurance. The monitor/ auditor will follow ... resources, and much more. Posted Job Title Clinical Research Monitoring Specialist Senior (Cancer Center) Job Profile Title Clinical Research Monitoring Specialist … more
- System One (Miami, FL)
- …of high quality data, timely adverse event reporting, subject protection and compliance to the protocol Adherence to ICH- GCP , regulatory requirements, local ... Senior Clinical Research Associate - Regional Location: Miami,...external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, Company SOPs and ICH- GCP… more
- Weill Cornell Medical College (New York, NY)
- …clinical research studies. **Job Responsibilities** + Coordinate clinical trials in compliance with federal regulations, GCP guidelines, and internal policies. ... to facilitate the screening, enrollment, and treatment of research subjects in compliance with established regulations and guidelines and internal SOPs. + Assists… more
- University of Rochester (Rochester, NY)
- …and non-departmental personnel to assure that this institution is in compliance with study guidelines as detailed on the individual treatment protocols. ... Ensure timely submission of this study data. Regulatory + Ensures compliance with acceptable regulatory requirements and IRB standards. The regulatory agencies… more