- 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
- Merck (Boston, MA)
- …technology. In particular this will include developing and maintaining a profound understanding of Good Clinical Practice ( GCP ) with respect to digital ... tools is required. + Expert knowledge of International Council for Harmonization Good Clinical Practice (ICH- GCP ) and worldwide Regulatory Health… 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
- Massachusetts Institute of Technology (Cambridge, MA)
- … and/or direct clinical research experience; supervisory/management experience; in-depth knowledge of Good Clinical Practice ( GCP ) in the conduct of ... researchers with other investigators across disciplines and institutions; facilitating clinical and translational research; developing knowledge of institutional/ practice… 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)
- …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
- J&J Family of Companies (Boston, MA)
- …with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice ( GCP ), and regulatory requirements. ... (Sr. LTM) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in...* Solid understanding of the drug development process including GCP and local regulatory requirements. * Willingness to travel… 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
- 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) **Research:** + Upon… 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
- AbbVie (Waltham, MA)
- …, Regulatory, Translational Science, and Pharmacovigilance departments to ensure compliance with Good Clinical Practice (s), and other applicable regulations. ... cancer therapies, we have the power to offer more good days to patients and their families ― now....intended for regulatory submission. + Ensure internal and external ( clinical sites/vendors/CROs) adherence to GCP , GLP, and… more
- Randstad US (Worcester, MA)
- …products skills: HPLC, Analytical Chemistry, Chemistry, 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
- Randstad US (Norwood, MA)
- …with safety protocols. skills: SOP, GLP ( Good Laboratory Practice ), GCP ( Good Clinical Practice ), Laboratory Information Management Systems ... (LIMS) 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 people of… 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