- System One (Andover, MA)
- Job Title: Quality Assurance Lead Investigator Location: Andover, MA Type: Contract Overview Leading pharmaceutical company looking for an experienced Quality ... + Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards + Ability to coordinate and facilitate meetings, lead… more
- Actalent (North Billerica, MA)
- …role of the Technical Writer involves supporting the team with specific quality events and revising, editing, and creating Standard Operating Procedures (SOPs) and ... work instructions. The position requires creating quality documents to ensure they adhere to all internal and regulatory standards, participating in cross-functional… more
- System One (Burlington, MA)
- Job Title: PRN Principal Investigator - Neurologist Schedule: Part-time Location: Burlington, MA Type: Contract (PRN, ~15 hours/month; open-ended assignment) ... Board-Certified Neurologist (MD/DO) to serve as a PRN Principal Investigator (PI) for a clinical research site. This is...get work done more efficiently and economically, without compromising quality . System One not only serves as a valued… 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
- State of Massachusetts (Boston, MA)
- …is to prevent illness, injury, and premature death, to assure access to high quality public health and health care services, and to promote wellness and health ... **Job:** **Compliance and Certification* **Organization:** **Department of Public Health* **Title:** *Nursing Investigator * **Location:** *Massachusetts-Boston-250 Washington Street* **Requisition ID:**… more
- Beth Israel Lahey Health (Boston, MA)
- …regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and ... medical record. Verifies information with clinical research nurse and/or principal investigator . May enroll patients onto clinical trials. (essential) + Monitors the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a ... global team focused on R&D Quality . This global role includes direct reports in the...clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) 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
- Merck (Boston, MA)
- …Adherence to GCP, local and global policies and procedures to conduct high- quality , inspection ready studies is essential. The position is accountable for trial ... quality and audit responses and completion of CAPAs. The...+ Leads strategic development and management of institutional & investigator relationships in conjunction with Research and Development/ GCD… more
- Bausch + Lomb (Boston, MA)
- …(eg, R&D/Project Management, Clinical/Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/Device Safety, and Clinical ... and changes in scope, schedule, and resources. + Organize investigator and expert meetings relevant to the indication and...ICH, GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,… 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 ... Human Research Studies (OHRS), and the Office of Data Quality (ODQ) to fulfill local and federal requirements governing...their resolution. + The CRM will assist the principal investigator in developing the protocol budget, in collaboration with… 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
- Children's Hospital Boston (Boston, MA)
- …oversee day-to-day coordination and overall management of Industry Sponsored and Investigator -initiated clinical trials, and quality improvement (QI) initiatives ... resource development and goal setting. * Consult on and support division-wide quality improvement initiatives. Educate involved staff and advise on methods, and… 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
- Sanofi Group (Waltham, MA)
- …Microbiologyor related Life Sciences with proven experience as a Principal Investigator or Postdoctoral Researcher and a strong publication record **Experience:** + ... in Immunology and Vaccines R&D, including experience as a Principal Investigator or Postdoctoral Researcher + State-of-the-art techniques in Immunology, Human… 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
- 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