- J&J Family of Companies (Boston, MA)
- …study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial /study safety, in keeping with protocols, GCP (Good ... day-to- day aspects of investigational site activities on assigned clinical trials . The Clinical Research...for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are… more
- Brown University (Providence, RI)
- …manage all aspects of both Investigational new drug (IND) exempt and non-exempt clinical trials in accordance with local and federal regulations, GCP guidelines ... designing and maintaining electronic data capture databases for new clinical trials , reviewing patient eligibility for ...staff as applicable, and ensuring overall compliance to the trial protocol. The Clinical Research Manager will… more
- Dana-Farber Cancer Institute (Boston, MA)
- … clinical research program and manages the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the ... Principal Investigator and the Clinical Trials Office. The Clinical ...Research Manager is responsible for tracking and complying with clinical trial performance benchmarks; eg protocol and… more
- Dana-Farber Cancer Institute (Boston, MA)
- …the Center of Cancer Therapeutic Innovation (CCTI) research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of ... we work with amazing partners, including other Harvard Medical School-affiliated hospitals. ** CLINICAL TRIAL OPERATIONS** + Assistant Clinical Research… more
- Children's Hospital Boston (Boston, MA)
- …and range from observational studies and registries to biobanking to interventional clinical trials of novel treatments. The Dana-Farber/Boston Children's Cancer ... be responsible for: + Oversight of their disease group's clinical trial portfolio and all related regulatory,...logistical, and regulatory challenges related to the conduct of clinical trials and acts as a leader… more
- Takeda Pharmaceuticals (Boston, MA)
- …Clinical Quality Compliance, you will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance ... monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is and aligned with applicable regulations. You… more
- Tufts Medicine (Boston, MA)
- …and ensures or produces meaningful reports that enable medical leadership to make clinical process decisions, and monitor and continually improve clinical ... Service Line services programs including procurement of equipment, the licensing requirements, clinical research trials , etc. + Ensures the efficient utilization… more
- State of Massachusetts (Taunton, MA)
- …development. As a key member of the residential team, direct-care staff must monitor and provide on-site and immediate intervention of DYS youth in our residential ... experienced and licensed Psychologist to fill the role of the Regional Clinical Coordinator- Southeast Region. The selected candidate will develop and oversee the… more
- Dana-Farber Cancer Institute (Boston, MA)
- …ensure spending adheres to budget and sponsor and Institute guidelines, invoice and monitor receivables for clinical trial enrollment when appropriate, ... funding types including federal, industry, foundation, donor, institutional, chargeback, and clinical trials . The Lead Research Administrator collaborates with… more
- Dana-Farber Cancer Institute (Boston, MA)
- …ensure spending adheres to budget and sponsor and Institute guidelines, invoice and monitor receivables for clinical trial enrollment when appropriate, ... funding types including federal, industry, foundation, donor, institutional, chargeback, and clinical trials . The Senior Research Administrator collaborates with… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of the Principal Investigator(s), Regulatory Operations Manager, and/or directly for the Clinical Trials Office to complete the regulatory requirements of the ... study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal… more
- WuXi AppTec (Boston, MA)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality control ... functions in accordance with Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and...onsite and remote), and close-out visits. + Completes all monitor and sponsor queries in a timely manner and… more
- Robert Half Legal (Boston, MA)
- …and compliance * Handle billing functions and claim administration related to contracts * Monitor and manage Clinical Trial Operations and Clinical ... * Experience in Billing Functions and Claim Administration * Understanding of Clinical Trial Operations and Clinical Trial Agreement * Bachelor's… more
- Actalent (Boston, MA)
- … research experience to act as a consultant CRC to support an ongoing Ophthalmology clinical trial . This CRC must be experienced in being able to work ... Part-Time Clinical Research Coordinator (20 hours/week) *This is a...source documents + E-diary compliance + Regulatory support + Monitor visits + Maintaining study binders + Subject follow-up… more
- Takeda Pharmaceuticals (Boston, MA)
- …data and technology for the implementation, optimization and maintenance of Takeda's clinical trial delivery operating model. The Senior Manager will contribute ... of one or multiple projects in support of the clinical trial delivery operating model. This will...compliance processes. + Comprehensive knowledge of regulatory requirements governing clinical trials and industry best practices. +… more
- AbbVie (Boston, MA)
- …for bringing people, process, and technology together to generate business value from clinical trial . Our operational model is exemplified through execution and ... of the organization and comply with industry standards. + Monitor project budgets, resource allocation, and timelines to ensure...to clinical data management. + Understanding of clinical trial methodologies, data collection processes, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …BST Lead will also oversee implementation of biomarker and bioanalytical strategies in clinical trials by working closely with BST biomarker and bioanalytical ... align on strategy and plans, and assure effective delivery of data to clinical trials to support decision making. _Accountabilities:_ + Responsible for… more
- Rhythm Pharmaceuticals (Boston, MA)
- …those or comparable experiences. + Thorough understanding of global and local clinical trial /study regulatory requirements and processes. + 5+ years' leadership ... Head, GCP Quality Assurance provides strategic leadership and direction for clinical quality assurance operations and other prioritized needs, ensuring Rhythm's drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …in enterprise-wide initiatives to improve speed/cost to market (eg innovative trial designs, improving governance processes, asset strategy etc.) GPLs must + ... development optimization initiatives such as refresh to asset strategy, innovative trial design etc. + Promotes organizational reputation by engaging with internal… more
- Robert Half Finance & Accounting (Boston, MA)
- …satisfaction * Utilize e-Copy for document management and record keeping * Support Clinical Trial Operations and Commission Functions with relevant data and ... Data Mining Techniques, and e-Copy * Must possess skills in Auditing, Clinical Trial Operations, Commission Functions, Communication, and Complaint Handling *… more