- Dana-Farber Cancer Institute (Weymouth, MA)
- …other Harvard Medical School-affiliated hospitals. Administrative: + Assists principal investigator with protocol development. + Assists principal investigator ... appropriate with the Institute's protocol review process. + Assists the principal investigator in developing the protocol budget. + Collaborates with the Dana-Farber… more
- Dana-Farber Cancer Institute (Boston, MA)
- …with the DFCI IRB contacts, clinical trial sponsors, DFCI designated Principal Investigator and the disease group Clinical Research Manager to facilitate and ... leadership / key stakeholders to identify, prepare, and ensure quality and regulatory compliance and completeness of all submissions into IRIS prior to submission. +… more
- Sanofi Group (Cambridge, MA)
- …CRF completion guidance, patient diary, etc.). + Develop training materials and lead investigator meetings. + Answer to medical questions raised by Ethics ... management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well… more
- Sanofi Group (Cambridge, MA)
- …development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary ... + Review, preparation, and/or contribution to questions from health authorities, ethics committees, IRBs, external partners + Management of product safety alerts… more
- Astellas Pharma (Cambridge, MA)
- …Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the ... training and quality control, to the highest level of compliance with ICH, GCP and Astellas policies. -Development, mentorship...level of personal commitment to the Astellas code of ethics . + Commits to the growth and organizational health… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Clinical Trials Monitor helps to ensure compliance of the clinical research enterprise with all related regulatory policies and guidelines, including federal, ... and related activities occur as outlined in the monitoring plan and in compliance with all related regulatory standards. Monitoring will be performed through a… more
- Stantec (MA)
- Grounded in safety, quality, and ethics , our experts lead their fields with dedication, a creative spirit, and a vision for growth. We draw from more than 20 ... Key Responsibilities - Act as the technical resource lead and/or Principal Investigator for complex, high-profile cultural resource investigations for a variety of… more
- Takeda Pharmaceuticals (Boston, MA)
- …lead preparation of responses to safety-related inquiries from regulatory agencies and ethics committees. + Ensure communication of all safety information that may ... in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents. + Demonstrate knowledge… more