Assist investigators in protocol development, as needed, and facilitate institutional approval and implementation.
Preparation and submission of IRB materials and protocols to appropriate review committees. CRC staff assists investigators in preparing protocol documents and consent forms that comply with Federal Regulations and RWJMS IRB standards.
Facilitate the conduct of clinical trials including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests and study visits, treatments, and assessment.
Provide oversight of trial conduct to assure adherence to IRB and GCP guidelines.
Maintain regulatory files for each study containing copies of all protocols, consent forms, IRB correspondence, investigational drug brochures and other study-specific documents
Provide customized protocol specific data collection tools.
Assist investigators in obtaining informed consent per GCP and FDA guidelines.
Monitor and document all adverse events and serious adverse events and reports to the IRB and sponsors in accordance with all Federal requirements.
Provide evening and week-end nursing and laboratory services for investigators.