- University of Miami (Miami, FL)
- …and escalating functional, quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual ... reports for delegated studies and works with the primary investigator and project team to assist in responding to...and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best… more
- Sumitomo Pharma (Tallahassee, FL)
- …the writing of clinical study reports + Contributes to the preparation of Investigator Brochures, annual reports, data collection systems and final reports in ... compliance with appropriate scientific/regulatory/medical standards + Contributes to developing...+ Contributes to the development of presentation materials for investigator meetings, health authority meetings, scientific advisory board meetings,… more
- Parexel (Tallahassee, FL)
- …in the delivery of monitoring + Supports the CRA to develop positive Investigator relationships throughout the life of the study and escalate any training or ... compliance concerns with Study Management ** Compliance with...and systems + Identifies and builds effective relationships with investigator site staff and other stakeholders + Effective verbal… more
- University of Miami (Miami, FL)
- …practice standards and clinical credentials as delegated by the Principal Investigator . + Monitors, documents, reports, and follows-up on study unanticipated/adverse ... in implementing protocol amendments under direct supervision of the Principal Investigator . + Assists with study orientation and protocol related in-services to… more
- University of Miami (Miami, FL)
- …and as required per UM policy. Under the supervision of the Principal Investigator . Determine data to be collected and develop forms for collecting/summarizing data. ... accuracy. Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.… more
- University of Miami (Miami, FL)
- …Specific Functions + Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic ... IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations. + Implements research protocols and monitors… more
- University of Miami (Miami, FL)
- …standards and clinical credentials as delegated by the Principal Investigator .6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events ... in implementing protocol amendments under direct supervision of the Principal Investigator .8. Assists with study orientation and protocol related in-services to… more
- University of Miami (Miami, FL)
- …to practice standards and clinical credentials as delegated by the Principal Investigator . 6. Monitors, documents, reports, and follows - up on study ... in implementing protocol amendments under d irect supervision of the Principal Investigator . 8. Assists with study orientation and protocol related in - services… more
- University of Miami (Miami, FL)
- …department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is ... responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and… more
- Merck (Tallahassee, FL)
- …and goals for approved, in-development, and active Company-sponsored trials and/or investigator -sponsored research studies. The RMSD serves as a role model for ... Enhances the comprehension of the scientific foundations and goals of investigator -sponsored research + Identifies barriers to patient enrollment and retention… more