- 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
- Beth Israel Lahey Health (Boston, MA)
- …committees on oncology human gene transfer trials. + Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. + Assist in ... just taking a job, you're making a difference in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel… 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 (Brookline, 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 (Milford, 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
- Beth Israel Lahey Health (Burlington, MA)
- …and general research duties. Implements study protocols in accordance to regulatory and institutional requirements. Works closely with principal investigators, ... assigned research studies by reviewing study and assessing protocol and institutional requirements: + Implements all study protocols in accordance with research… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and reviews as requested. + Assist with documentation for and communication with institutional review board . + Other project-related or administrative ... specifically focus on overseeing and conducting research projects, including regulatory work, participant recruitment, interviews, transcribing, and ensuring the… more