- 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, and best practices to ensure understanding and… more
- Philips (Cambridge, MA)
- The Senior Good Clinical Practice ( GCP ) Auditor will play a critical role in ensuring Philips' Clinical Studies and practices are compliant with ... Internal/External regulatory and quality standards. **Your role:** + Executing & leading Good Clinical Practice ( GCP ) audits in line with defined… more
- Sanofi Group (Cambridge, MA)
- …plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as well… more
- Boston University (Boston, MA)
- …options. This person will organize, maintain and develop current and new educational offerings on Good Clinical Practice ( GCP ) and proper conduct of ... working with small and large groups of people. + Demonstrated knowledge of clinical /human research conduct, GCP , Federal regulations guiding human research (21… more
- Children's Hospital Boston (Boston, MA)
- …+ Ensure that research activities completed by study staff are performed in compliance with Good Clinical Practice ( GCP ) and program standards. Ensures ... Research Manger will develop and oversee the implementation of best practice guidelines for conducting various clinical research protocols, collaborate with… more
- Sanofi Group (Cambridge, MA)
- …plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... The Principal Clinical Research Director is the **primary senior clinical lead for a clinical development program** , reporting into the Global Project Head… more
- Sanofi Group (Cambridge, MA)
- …plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... **Principle Clinical Research Director - Gastronenterology** The Principle Clinical Research Director (CRD) is noted as the primary clinical lead for complex… more
- Philips (Cambridge, MA)
- …administration or a related field. + Your skills include a strong understanding of Good Clinical Practice ( GCP ) regulations and regulatory requirements ... ** Clinical Operations Manager - Clinical Data Intelligence** You will be responsible for Clinical Operations Management for research partnerships related to… more
- Sanofi Group (Cambridge, MA)
- …2 studies + Assure successful execution of the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations as ... **Senior Clinical Research Director, Early Development** The Senior Clinical Research Director (Sr CRD) supports several early stage programs and manages a team… more
- IQVIA (Boston, MA)
- …team + In-depth knowledge of applicable clinical research regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on ... of R programming as well as SAS(R) Base, and good knowledge of SAS(R) graph and SAS(R) Macros. +...+ Excellent application development skills. + Strong understanding of clinical trial data and extremely hands on in data… more
- IQVIA (Boston, MA)
- …close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference ... the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding… more
- Merck (Boston, MA)
- …Global Medical Scientific Affairs (GMSA) strategy, including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and ... policies. + Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for your specific… more
- Randstad US (Cambridge, MA)
- …and comfortable with shifting priorities and change in a small company environment skills: SOP, GCP ( Good Clinical Practice ), ICH Regulations, TMF Equal ... and ICH GCP guidelines to ensure the appropriate conduct of clinical studies + Good verbal and written communication skills + Good organizational skills… more
- Randstad US (Worcester, MA)
- …skills: Molecular Biology, Cell Biology, PCR, Biology, GLP ( Good Laboratory Practice ), GCP ( Good Clinical Practice ), GMP ( Good Manufacturing ... Practice ) Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome… more
- WuXi AppTec (Natick, MA)
- …and office-based monitoring and data quality control functions in accordance with Good Clinical Practices ( GCP ), International Conference on Harmonization ... these years being oncology-based monitoring experience. + Experience using Good Clinical Practices and a good...Must possess a thorough understanding of FDA Guidelines, ICH, GCP , NDA, IND, and other applicable regulations. + Ability… more
- Beth Israel Lahey Health (Boston, MA)
- …required in clinical trials and/or regulatory. 3. Solid understanding of FDA good clinical practice guidelines 4. Ability to maintain confidential and ... 40 **Work Shift:** Day (United States of America) The Clinical Trials Monitor (CTM) monitors and audits the investigator-initiated...of research quality. (essential) + Competent in ICH E6 ( GCP /GLP/GCLP), ICH Q9, 21 CFR, GDPR and, HIPAA laws… more
- Pfizer (Cambridge, MA)
- …+ MBA/MS/ 6+ years of relevant experience + BS/BSc/MS/MSc + Working knowledge of Good Clinical Practice , clinical and regulatory operations and ... more studies, in accordance with the appropriate quality standards including ICH/ GCP standards, SOPs, local operating guidelines and local regulatory requirements,… more