- University of Rochester (Rochester, NY)
- …interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board ( IRB ), Sponsor, and/or any other ... adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and...forms and CRFs, are complete, accurate, and available for review . Communicates with Sponsor to clarify data queries to… more
- University of Rochester (Rochester, NY)
- …met before enrollment. + Document adverse events and report to senior study staff, PI, Institutional Review Board ( IRB ), Sponsor, and/or any other ... adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and...forms and CRFs, are complete, accurate, and available for review . + Communicates with Sponsor to clarify data queries… more
- Mount Sinai Health System (New York, NY)
- …grant applications and documents and assists in protocol submissions (for eg, Institutional Review Board , Grants and Contracts Office). **Qualifications** ... evaluation of the study subjects. 3. Prepares and ensures grant applications, IRB /GCO documents are submitted. 4. Ensures accurate and complete compilation of… more
- University of Rochester (Rochester, NY)
- …regarding the overall OHSP, including, but not limited to: (a) determining when IRB review is necessary; (b) identifying appropriate categories of review ... use of, and technical support for, the electronic submission system (Click IRB ); and (d) the institutional education/training program. + Building relationships… more
- Mount Sinai Health System (New York, NY)
- …committees' inquiries. 3. Gathers data needed to prepare and process applications for IRB review and approval. 4. Collaborates with the Principal Investigator ... **Job Description** The Regulatory Compliance Coordinator I works with investigators, consortiums,...combination of education and applicable experience (preferred: research or regulatory ) + 3 years of experience in clinical research… more
- Mount Sinai Health System (New York, NY)
- …administrative review and approval of protocols that do not require full board review , including determination and issuance of waivers, exemptions, and other ... to detail and accuracy **Responsibilities** + **Ensure the smooth operation and regulatory compliance of Protocol Review and Monitoring Committee (PRMC) and… more
- Stony Brook University (Stony Brook, NY)
- …that involve any transfers of protected data related to a research activity including the review Institutional Review Board submissions as needed and ... guidance to SBM leadership and staff on requirements and regulatory topics pertaining to research and academic compliance. +...lead the Data Use Agreement Review Committee. The DCRCP further reviews certain non-disclosure agreements,… more
- Actalent (Syracuse, NY)
- …and maintain regulatory documents. + Prepare Informed Consent Documents with institutional language. + Interface with the IRB , preparing all required ... (GCP). This role involves daily interactions with clinicians, sponsors, IRB , regulatory agencies, and other research professionals....documents and submitting packages for review . + Collaborate with the recruitment team to create… more
- Mount Sinai Health System (New York, NY)
- …in the preparation and submission of grant applications and documents (eg, Institutional Review Board , Grants and Contracts Office). **Qualifications** ... telephone calls. + Assists in the collection, analysis and review of experimental data for publication and presentation. +...the protocol. + May assist in the preparation for regulatory agency site visits. + Performs other related duties… more
- Weill Cornell Medical College (New York, NY)
- …schedule of events. + Reports all Adverse Events and Serious Adverse Events (SAEs) to Institutional Review Board and other agencies, as required. + Functions ... conjunction with all pertinent staff, including: the monitor/auditor, the regulatory office, investigational pharmacy, and investigators. + Maintains and… more