- Dana-Farber Cancer Institute (Brookline, MA)
- …applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval + Prepares and submits regulatory documentation ... Create and maintain tracking for all subsequent submissions to the SRC / IRB ; protocol & consent amendments, all required safety reporting, all required deviation,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …samples, maintaining regulatory binders, and ensuring compliance with all institutional , state, and federal regulations, including IRB requirements. ... start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities. + Responsible for data… 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
- Dana-Farber Cancer Institute (Foxborough, MA)
- …site regulatory binders and ensures study compliance with all state, federal, and IRB requirements. May be responsible for site IRB submissions (violations, ... the Regional Campus site(s). + Prepare and/or complete regulatory related reports and IRB submissions as it pertains to the regional campus' studies. Maintain and… 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 of ... Subjects Protection training (CITI) and any additional training as specified by the IRB prior to beginning any actual work on research protocols. IATA certification… more
- Harvard University (Cambridge, MA)
- …organization and quality checking of survey data to ensure all documented IRB protocol procedures are followed and data is collected correctly. Experience working ... with human subjects and associated research regulations, including the IRB is important part of tole. For lab-based studies, s/he will have access to state of the… more
- Norstella (Boston, MA)
- …the product meets customer needs and project goals. + Maintain familiarity with IRB , EC approval requirements, and GCP guidelines to ensure each project complies ... trial life cycle & processes, industry standard patient recruitment strategies, IRB /EC approval requirements, and GCP guidelines is a plus. + Detail-oriented… more
- Harvard University (Cambridge, MA)
- …organization and quality checking of survey data to ensure all documented IRB protocol procedures are followed and data is collected correctly. Experience working ... with human subjects and associated research regulations, including the IRB , is an important part of role. For lab-based studies, s/he will have access to state of… more
- Norstella (Boston, MA)
- …our solutions. + Ensure all work complies with relevant regulatory requirements (eg, IRB , EC, GCP) and data privacy standards. + Mentor junior project managers and ... of clinical trial operations, patient recruitment strategies, regulatory requirements ( IRB /EC), and GCP standards. + Proficiency in project management tools… more
- Beth Israel Lahey Health (Boston, MA)
- …submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting ... on oncology human gene transfer trials. + Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns. + Assist in the preparation… more