- 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 ... + Training and Education: They may provide training to clinical trial personnel on GCP requirements, SOPs,...system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring… 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 ... standards. **Your role:** + Executing & leading Good Clinical Practice ( GCP ) audits in line with...minimum of 7+ years' experience working in FDA regulated Quality Management Systems (QMS)/ Clinical environments, with a… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Senior Manager, Global Development Quality Management ( GCP ) acting as a Quality Management Lead (QML) is a key position that will provide mentorship ... with study teams, relevant functions and other GDQ functions. Lead risk-based quality activities on all Regeneron-sponsored clinical trials, inclusive of issue… more
- Ascendis Pharma (Palo Alto, CA)
- …oversight of the compliance, quality , standards and training within the Good Clinical Practice and Pharmacovigilance ( GCP /GVP) areas, with an emphasis on ... and audit program in assuring quality risk management/mitigation, including performing GCP audits of internal processes, vendors and clinical trial sites. +… more
- AbbVie (North Chicago, IL)
- …and LinkedIn. Job Description Key Responsibilities + Responsible for ensuring high quality clinical trials are performed in compliance with worldwide regulatory ... the clinical trial conduct and their overall compliance with ICH GCP guidelines, applicable regulations, and the organization's Quality System. + Appropriate… more
- United Therapeutics (Durham, NC)
- …Excellent understanding of the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality control in clinical ... oversight of sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality metrics, building… more
- University of Colorado (Aurora, CO)
- …Clinical Research Support Team (CReST) has an opening for a full-time Senior Clinical Research Coordinator to provide regulatory, study coordination, and data ... Clinical Research Senior Coordinator - 28335...(SOPs), and research standards and best practices (ICH Good Clinical Practice ( GCP ), and Good Documentation Practices… more
- IQVIA (Durham, NC)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...clinical risks through the project lifecycle. * Ensure clinical quality delivery by identifying quality… more
- University of Michigan (Ann Arbor, MI)
- Clinical Research Coord Senior Apply Now **How to Apply** A cover letter is required for consideration for this position and should be attached as the first page ... to enhance subject safety during the conduct of a clinical study + Oversees regulatory documentation for quality...employer. **Job Detail** **Job Opening ID** 246785 **Working Title** Clinical Research Coord Senior **Job Title** … more
- University of Colorado (Aurora, CO)
- Research Services Senior Pro- Clinical Sciences - 29439 University Staff **Description** **University of Colorado Anschutz Medical Campus** **Department: ... Dermatology** **Job Title: Research Services Senior Pro- Clinical Sciences** **Position: # 00807887- Requisition:... research, such as understanding federal regulations and Good Clinical Practice ( GCP ) **Knowledge, Skills, and Abilities:**… more
- IQVIA (Anacortes, WA)
- IQVIA is seeking Senior Clinical Research Associate IIs and Senior Clinical Research Associate IIIs based in the Mid-West, US and Northwest, US. Ideal ... contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on...manage ongoing project expectations and issues. * Evaluate the quality and integrity of study site practices related to… more
- e CancerCare (Fresno, CA)
- …Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential ... staff, subIs, and PIs complete and maintain appropriate certifications specific to clinical trial participation ( GCP , Conflict of Interest, FDA Focused, and… more
- WuXi AppTec (Austin, TX)
- …be made and every disease can be treated." **Responsibilities** **Job Summary:** The Senior Clinical Research Associate is a critical position within the ... and is assigned as a study lead to manage clinical trial studies. The Senior CRA will...+ Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Senior ...GCP guidelines as well as applicable SOPs regarding clinical safety + Performs clinical /medical data review,… more
- Merck (Columbus, OH)
- …and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous ... clinical trials conducted worldwide. In collaboration with the Clinical Quality Operations Lead {CQOL and Head...require headquarters input. Other Responsibilities + Provides input into GCP Quality and Compliance Council regarding the… more
- ARTIDIS (Houston, TX)
- About ARTIDIS ARTIDIS AG is a clinical -stage health-tech start-up company founded in Basel, Switzerland that has developed the first nanomechanical biomarker for ... treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, intended to allow… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply ... strong relationships with BeiGene functional leadership (including but not limited to clinical Operation, Quality , Regulatory, CMC, and GRDS) to ensure alignment… more
- WuXi AppTec (Natick, MA)
- …monitoring and data quality control functions in accordance with Good Clinical Practices ( GCP ), International Conference on Harmonization (ICH), and WuXi ... **Overview** The Clinical Research Associate III Senior Oncology...documentation of activities and findings as required by WuXi Clinical and sponsor. + Performs data quality … more
- University of Colorado (Aurora, CO)
- Clinical Sciences Professional, Open-Rank Entry, Intermediate and Senior - 32889 University Staff **Description** **University of Colorado Anschutz Medical ... Campus** **Department: Orthopedics** **Job Title: Clinical Science Research Professional - Open Rank (Entry- Senior...+ Knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ) + Ability to communicate… more
- University of Colorado (Aurora, CO)
- Clinical Research Coordinator (Entry - Senior Level) - 32978 University Staff **Description** **University of Colorado Anschutz Medical Campus** **School of ... Medicine | Department of Psychiatry** **Job Title:** ** Clinical Research Coordinator (Entry - Senior Level)**...+ Knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ). + Ability to communicate… more