- Beth Israel Lahey Health (Boston, MA)
- …IRB . Interact with the FDA on emergency use of a test article without IRB review applications. (essential) + Assist in preparation of FDA, cooperative group ... authorities. (essential) + Act as a liaison between the IRB and investigator to resolve regulatory queries...between the IRB and investigator to resolve regulatory queries and concerns. (essential) **Required Qualifications:** + Bachelor's… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval + Prepares and submits regulatory documentation that may ... various regulatory reporting required are met; Study Sponsor, FDA, IRB etc. **Key Stakeholder Interfacing** + Establishing and maintaining regular communication… more
- Tufts Medicine (Boston, MA)
- …study sponsor and Institutional Review Board . 5. Assists with Institutional Review Board ( IRB ) requirements for each study including meeting ... institutional educational requirements, submitting documents for review such as amendments, adverse event reporting and annual reviews. 6. Performs basic… more
- Boston University (Boston, MA)
- …and verify adherence to applicable regulations, laws, and policies and to the IRB approved protocols. This individual conducts on-site and remote reviews of IRB ... the QA role, this individual will provide assistance to clinical researchers regarding regulatory aspects to the conduct of research throughout the life of the… more
- Fenway Health (Boston, MA)
- …alignment on the status of projects. + Regulatory Compliance:Assist with all Institutional Review Board ( IRB ) submissions concerning protocol changes ... and annual reviews. Prepare and submit these documents to the IRB with the approval and assistance of the site Principal Investigator or research scientist, ensuring… more
- Dana-Farber Cancer Institute (Boston, MA)
- …the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. + ... and resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …samples, maintaining regulatory binders, and ensuring compliance with all institutional , state, and federal regulations, including IRB requirements. The CRC ... start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site...resolution of data queries. + Prepare and or complete regulatory related reports and IRB submissions. Maintain… more
- Dana-Farber Cancer Institute (Foxborough, MA)
- …queries for all studies at the Regional Campus site(s). + Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the regional ... for the primary data collection, management of patient clinical information, and regulatory documents as it pertains to participation in clinical trials across all… more
- Norstella (Boston, MA)
- …on clinical trials, drug treatments, medical devices and what's new in the regulatory and commercial landscape. Relying on us to deliver vital advantage when making ... global pharma and CROs. From drug and device discovery and development to regulatory approval, and from product launch to lifecycle management, we provide the… more
- Baystate Health (Springfield, MA)
- …and data. 14) May assist with sponsor/CRO visits. 15) Adheres to protocol, IRB , HIPAA, and regulatory requirements. **Required Work Experience:** **1)** 2 years ... 11) Contribute to the preparation, submission, and maintenance of regulatory documents. 12) Performs actual study tasks as directed....(CITI) and any additional training as specified by the IRB prior to beginning any actual work on research… more
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