- Actalent (North Billerica, MA)
- …training on investigation techniques and quality system requirements. Essential Skills + Quality assurance + Investigator + Root cause analysis + CAPA + ... Job Title: Quality InvestigatorJob Description Lead and manage complex investigations related to deviations, non-conformances, and quality events across… more
- System One (Burlington, MA)
- Job Title: PRN Principal Investigator - Endocrinologist Schedule: Part-time Location: Burlington, MA Type: Contract (PRN, ~15 hours/month; open-ended assignment) ... and responsive Board-Certified Endocrinologist (MD/DO) to serve as a PRN Principal Investigator (PI) for a clinical research site in Massachusetts. This is a… more
- Takeda Pharmaceuticals (Boston, MA)
- …job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION:** Research Investigator Analytical Development **POSITION DESCRIPTION** : Takeda Development Center ... Americas, Inc. is seeking a Research Investigator Analytical Development with the following duties: Independently design, plan and execute studies on new development… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Investigator , Ethics and Business Integrity, North America **Location:** Cambridge, MA **About the Job** Ready to push the limits of what's possible? ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- Beth Israel Lahey Health (Boston, MA)
- …(BIDMC). The Clinical Research Coordinator Core provides support for investigator -initiated and sponsor-initiated research for investigators across the departments ... regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and… more
- Dana-Farber Cancer Institute (Boston, 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
- Beth Israel Lahey Health (Boston, MA)
- …coordinate clinical research protocols, as directed by the Program Manager or Principal Investigator (PI). The CRC will also have the opportunity to learn certain ... patient assessments such as collection of electrocardiograms. There may be regulatory and quality exposure in this position. The position typical hours will be from… more
- Dana-Farber Cancer Institute (Boston, MA)
- …trials using Good Clinical Practice under the auspices of the Principal Investigator and the Clinical Trials Office. The Clinical Research Manager, in collaboration ... the Office for Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing human clinical trials. +… more
- Sumitomo Pharma (Boston, MA)
- …Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), Investigator 's Brochures (IB), Investigator communications (Dear Health Care Provider ... (SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives,… more
- Organon & Co. (Boston, MA)
- …oversight thereof while ensuring the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical Pharmacology function in asset ... 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, IND subsections, briefing books, submission modules, responses to… more
- Chiesi (Boston, MA)
- …than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the ... identify new collaborative KOL relationships for advisory boards, company-sponsored, investigator -initiated research, and speaker development + Provide field insights… more
- Beth Israel Lahey Health (Boston, MA)
- …productivity, as applicable. + Execute the budget process to develop annual investigator , core or other budgets according to assigned portfolio. + Assist with ... requested. + Request sponsor authorization as necessary on changes in principal investigator , scope of work, key personnel effort, performance site, or proposed… more
- Sanofi Group (Boston, MA)
- …and identifying opportunities for further data collection clinical or investigator -led** + Monitors disease epidemiology and provides support, including protocol ... as requested. + Responds to unsolicited requests regarding interest in investigator sponsored studies (ISS) and supports ISS submissions through appropriate internal… more
- BeOne Medicines (Boston, MA)
- …relevant regional medical meetings (eg, advisory boards, consultant, and investigator meetings), as requested + Identification and verification of investigators ... as a liaison for the submission and review of Investigator Sponsored Research proposals + Support major and regional...ability to drive results at a high level of quality as a strategic and creative thinker + Demonstrates… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Regulatory Coordinators (RC) works under the direction of the Principal Investigator (s), Regulatory Operations Manager, and Clinical Research Manager to complete the ... interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Multidisciplinary Cancer Research Program with Brigham and Women's Hospital, Investigator Training Initiatives, Relations with industry sponsors, Collaboration with ... project reporting and interpretation of data + Identifies opportunities for quality improvement + Works to develop infrastructure improvement processes, and track… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …this new initiative. The RC will work under the direction of the Principal Investigator (s), and will directly report into the Clinical Trials Office to complete the ... interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various DF/HCC institutions.… more
- Sanofi Group (Cambridge, MA)
- …Medical Director--CNS Inflammatory Diseases will also execute activities related to investigator and expert (KOL/HCP) outreach, investigator sponsored trials, ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more
- Massachusetts Institute of Technology (Cambridge, MA)
- …Center for Clinical and Translational Research, will work closely with the Principal Investigator (PI) of the MIT VPR Center for Clinical and Translational Research ... foundations ensuring that objectives and timelines set by the Principal Investigator /Project Lead are clearly defined and communicated.Find the full job description… more
- Astellas Pharma (Cambridge, MA)
- …goals and objectives of the Oncology Solid Tumor Development team. Accountable for quality in all work products of the team, ensuring efficiency in clinical ... medical science specific global standards, processes, SOPs, training and quality control, to the highest level of compliance with...in pharma or pharma and/ or as a clinical investigator in academia, particularly in the Oncology Solid Tumor… more