- Merck (Tallahassee, FL)
- …activities including our Company sponsored trials and our Company Independent Investigator Study Programs as prioritized and requested by our Research Development ... requested by our Research & Development Division's leadership, including our Company's Investigator Study Program (ISP), by acting as the primary liaison to… more
- ThermoFisher Scientific (Alachua, FL)
- …**Essential Functions and Other Job Information:** **Essential Functions** + Monitors investigator sites with a risk-based monitoring approach; applies root cause ... site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF… more
- HCA Healthcare (Port Charlotte, FL)
- …subjects according to protocol requirements + Responsible for working with the principal investigator to meet or exceed study enrollment. + Reviews the study design ... study patients by verifying informed consent procedures and adhering to protocol requirements/ compliance + Ensures the integrity of the data submitted on Case Report… more
- University of Miami (Miami, FL)
- …system and performs ocular diagnostic testing using specialized instrumentation in compliance with department standards. JOB FUNCTIONS + Performs diagnostic testing ... as well as any modality requested by a sponsor or principal investigator . + Certifies and performs all clinical research assessments including full-field stimulus… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …requires strong cross-functional collaboration with Medical Affairs, Legal, Compliance , Finance, and external partners. **Job Description** **Key Responsibilities ... generation of medical evidence, (eg, observational studies, registries, and investigator -initiated studies (IISs) / investigator -initiated trials (IITs)) + Manage… more
- Sumitomo Pharma (Tallahassee, FL)
- …closely with Regulatory Operations in the electronic submission + Ensure compliance with global regulatory requirements and adherence to regulatory internal policies ... and processes and coordinate regulatory compliance activities at a global level + Provide updates to the Global Regulatory Team, project teams, and governance boards… more
- Parexel (Tallahassee, FL)
- …monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and ... meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and… more
- University of Miami (Miami, FL)
- …as needed. It will monitor recruitment targets and adherence to research compliance and University of Miami policies. The Manager, Clinical Research (A) oversees ... and escalating functional, quality and timeline issues appropriately. + Manages investigator relationships. + Maintains IND and IDE documentation, including annual… 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 ... 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)
- …and a solid foundation in research methods. The CRC3 will assist the Principal Investigator , Dr. Tracy Crane, and Director of Research for the CRANE Lab on oversight ... (SOPs), study manuals, and templates with guidance from the Principal Investigator (PI) or Clinical Research Manager. Oversees and facilitates eligibility screening… more