- Emory Healthcare/Emory University (Atlanta, GA)
- …the audit plan and client representatives. + Ensures that all human subject or clinical trial audit reports are accurate and of the highest professional ... excellence of our academic community. **Description** Performs audits of clinical trials to ensure compliance with federal...audits. + Educates study teams on GCP and Emory clinical trial requirements. + Participates in project… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12071BR** **Title:** Sr Auditor , Clinical Trials **Job Description:** Provide support to all aspects of the Clinical Quality Assurance (CQA) function ... on technology for communication and handling confidential information. **External-Facing Title:** Sr Auditor , Clinical Trials **Posting Country:** US -… more
- Hackensack Meridian Health (Edison, NJ)
- …education on all areas of research compliance. This includes: FDA regulated clinical trials , human subjects research, federally and industry sponsored research. ... as a leader of positive change. The Research Compliance Auditor is a key contributor to HMH's Research Compliance... is a key contributor to HMH's Research Compliance Audit and Monitoring Program (RCAMP) which is responsible for… more
- Pfizer (New York, NY)
- …ICH, and National regulations). **ROLE RESPONSIBILITIES** + Assesses compliance of GCP clinical trial sites and processes against ICH GCP and applicable ... **ROLE SUMMARY** The Manager, Auditor is responsible for the delivery and execution...and execution of the global Quality Assurance (QA) program audit activities on assigned GCP portfolio/programs/entities. This role is… more
- ICON Clinical Research (Salt Lake City, UT)
- …* Knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials * Knowledge of CAPA management, including performing root cause ... Quality Assurance Auditor II - US, Salt Lake City, UT...Office/Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive… more
- Catalent Pharma Solutions (Harmans, MD)
- …release of drug substance and/or final drug product to support Phase I/II clinical trials ; potential work with clients during initial and subsequent ... **Manager, Quality Systems Audit ** **Position Summary** Catalent is a global, high-growth,...sizes to advance new medicines from early development to clinical trials and to the market. Catalent… more
- Stanford University (Stanford, CA)
- …the Department of Dermatology span a wide range of efforts, ranging from clinical trials to molecular translational medicine to fundamental studies in epithelial ... federal, industry and non-profit sponsors on contracts, grants and clinical trials . Dermatology is looking for a...pre- and post-award sponsored research activities and services, including clinical trial preparation, clinical … more
- Catalent Pharma Solutions (Greenville, NC)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... business unit. On site we have our state-of-the-art laboratory, clinical , and commercial manufacturing plant for oral dose forms...Role:** + Oversight and leadership for the regional Supplier Auditor Team performing audits, generation of audit … more
- University of Rochester (Rochester, NY)
- …operation and evaluation of divisional procedures required to ensure quality clinical trial research within the Division of Pediatric Hematology/Oncology. ... IRB standards. The regulatory agencies include the University IRB, clinical trials office, and the FDA. Ensure...audit , he/she will collect all study documents for auditor review. **Qualifications:** Bachelor's degree with major course work… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …are adequately addressed. - + Oversees staff that reviews billing compliance related to clinical trials . + Interacts with all levels of management within the ... supervisory/ managerial experience. Knowledge of medical records/coding/billing processes relating to Clinical Trials and knowledge of regulations pertaining to… more
- Astellas Pharma (Westborough, MA)
- …a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials ) and other ocular indications to vascular and autoimmune ... support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate...for these programs. + May assist with the Internal Audit program for the organization, serving as an assistant… more
- Astellas Pharma (Westborough, MA)
- …a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials ) and other ocular indications to vascular and autoimmune ... support of GMP manufacturing programs as AIRM moves through clinical trials and commercialization. The successful candidate...for these programs. + May assist with the Internal Audit program for the organization, serving as an assistant… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... excipient manufacturing operations. + Experience preparing audit plans, audit reports, audit responses. + Auditor certification and/or RAC certification… more
- Bristol Myers Squibb (Devens, MA)
- …talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials , while our shared values of passion, innovation, urgency, ... **Position Summary** This position will support the external supplier audit program and serve as a Subject Matter Expert...audit program as a team member and/or lead auditor . Serves as a Subject Matter Expert SME for… more
- Astellas Pharma (Westborough, MA)
- …a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials ) and other ocular indications to vascular and autoimmune ... M-TC's cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization. This position is responsible for… more
- Catalent Pharma Solutions (Harmans, MD)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... the expected turn-around time * Manages Gene Therapy Supplier Audit Schedule and Annual audit planning; tracks...11; ASQ CQA (American Society of Quality Certified Quality Auditor ) highly desirable * Experience within Quality Risk Management… more
- Stanford University (Stanford, CA)
- …projects, involving multiple sub-awards, principal investigators, and/or interdisciplinary initiatives, clinical trials , and occasional pre-award duties. This ... aides. + Manage contract and grant annual reporting, closeout process and audit inquiries; submit final reports and certificates. + Interpret complex university and… more