- Children's Hospital Boston (Boston, MA)
- …and prepares new protocol applications for submission to the Heart Center's Scientific Review Committee, the Boston Children's Hospital IRB , and our central ... IRB . Prepares and submits continuing reviews and protocol amendments to the IRB for ongoing studies. Corresponds with the IRB . + Coordinates weekly meetings… more
- Children's Hospital Boston (Boston, MA)
- …electronic protocol submission, completing amendments and continuing reviews, communicating with the Institutional Review Board . + Working in concert with ... submission of new protocols. This includes but is not limited to: literature review , editing study-related documents such as subject files, consent forms, data entry… more
- Norstella (Boston, MA)
- …and continuous improvement of our solutions. + Ensure all work complies with relevant regulatory requirements (eg, IRB , EC, GCP) and data privacy standards. + ... + Deep understanding of clinical trial operations, patient recruitment strategies, regulatory requirements ( IRB /EC), and GCP standards. + Proficiency in… 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
- Massachusetts Institute of Technology (Cambridge, MA)
- …projects; identify and resolve bottlenecks or delays; ensure adherence to IRB protocols, sponsor timelines, and regulatory compliance; maintain documentation ... - wet lab and/or clinical; familiarity with clinical research protocols, regulatory documents, and IRB procedures; exceptional organizational and communication… more
- Bausch + Lomb (Boston, MA)
- …the timely coordination and execution of clinical study reports. + Assist in the review of regulatory reports to ensure that reports accurately reflect proper ... evaluation, and selection of CROs and vendors (eg, central labs, central IRB , IVRS, etc.). + Manage the identification, evaluation, and selection of… more
- Dana-Farber Cancer Institute (Boston, MA)
- …specimen tracking systems (STIP) and laboratory binders. + May be responsible for IRB and regulatory submissions and maintenance of regulatory files. ... Specialist will be responsible for the collection, management, and quality assurance review of patient clinical data. Located in Boston and the surrounding… more
- Nanobiosym, Inc. (Cambridge, MA)
- …and international tax regulations while managing government contracts and healthcare-related regulatory requirements (eg, FDA, IRB approvals, and liability ... environment and is ready to tackle a wide range of legal, regulatory , and compliance challenges. The ideal candidate is a skilled negotiator, exceptional… more
- Dana-Farber Cancer Institute (Boston, MA)
- …specimen tracking systems (STIP) and laboratory binders. + May be responsible for IRB and regulatory submissions and maintenance of regulatory files. ... Data Specialist will be responsible for the collection, management, and quality assurance review of patient clinical data. The Research Data Specialist will play a… more