- Boston University (Boston, MA)
- **CIVIL RIGHTS INVESTIGATOR , Equal Opportunity** **Job Description** **CIVIL RIGHTS INVESTIGATOR , Equal Opportunity** **Category** Charles River Campus --> ... subject matter expertise. The primary responsibility of the Civil Rights Investigator is to conduct prompt, thorough, and impartial investigations into reports… more
- Dana-Farber Cancer Institute (Weymouth, MA)
- …other Harvard Medical School-affiliated hospitals. Administrative: + Assists principal investigator with protocol development. + Assists principal investigator ... the Institute's protocol review process. + Assists the principal investigator in developing the protocol budget. + Collaborates with...Patient Care Services. + Adheres to the Code of Ethics for Nurses with Interpretive Statements (ANA, 2001) in… more
- Sanofi Group (Cambridge, MA)
- …abstracts and/or manuscripts; clinical pharmacology or ECET components of investigator brochures, regulatory documents. + Interact effectively with managers from ... clinical trial vendors, clinical and scientific experts, Key Opinion Leaders, ethics committees, Health Authority representatives. **At the clinical study level, the… 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 ... all submissions into IRIS prior to submission. + Assist the principal investigator in developing the protocol budget in collaboration with Research Administration… 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 ... + Review and/or contribute to the clinical section of the Investigator 's brochure, Clinical Trial Application (CTA), Investigational New Drug (IND), Risk… 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
- Takeda Pharmaceuticals (Boston, MA)
- …+ At least 5 years of experience as a study medical monitor, sub- investigator and/or principal investigator in dermatology is required; specific experience in ... skills as applied to medical, scientific and technical information. + Unquestioned ethics are a must. **Complexity and Problem Solving:** + Management of discrete… 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 ... level of personal commitment to the Astellas code of ethics . + Commits to the growth and organizational health...in pharma or pharma and/ or as a clinical investigator in academia, particularly in the Oncology Solid Tumor… 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
- Dana-Farber Cancer Institute (Brookline, MA)
- …partners, including other Harvard Medical School-affiliated hospitals. + Ensure the Sponsor- Investigator and study team adhere to current FDA regulations, applicable ... staff as well as research support personnel. + Must have expertise in research ethics and the responsible conduct of research. Located in Boston and the surrounding… more