- University of Miami (Miami, FL)
- …alternative language, as required. Communicates (telephone, email, meetings) with principal investigator and key senior leadership authors as necessary to ensure the ... accuracy and clarity of documents; meets both internal and sponsor submission deadlines. Researches, composes and edits clinical/statistical reports and study protocols. Summarizes data from clinical studies for submission to appropriate… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …clinical pharmacology documents for regulatory filings including annual reports, investigator 's brochure, IND/NDA applications and pediatrics development plans. + ... Work with bioanalytical team members on activities related to sample management, pharmacogenomics and biomarker development and provide analysis support related to PK, PBPK and PK/PD. + Work with formulation development groups and provide support for PK and… more
- MUFG (Tampa, FL)
- …Senior Fraud Prevention Manager (Vice President) of Fraud Operations. The Investigator will complete fraud investigations to ensure that potentially suspicious ... transactions are appropriately identified within specified timeframes and that decisions to file or not to file Suspicious Activity Reports (SARs) are adequately supported. This is a non-supervisory position, distinguished from the higher-level investigators… more
- HCA Healthcare (Sarasota, FL)
- …and will also work closely and effectively with physician principal investigator (s), resident(s), fellow(s), research directors, other members of the scholarly ... support team, and multiple internal clients. This role supports GME Research at HCA Florida Blake Hospital and HCA Florida Sarasota Doctors Hospital **. Candidate must be able to travel and work at both facilities.** DUTIES INCLUDE BUT NOT LIMITED TO: +… more
- AdventHealth (Altamonte Springs, FL)
- …Phase I-IV industry-sponsored, grant funded (federal or other grants), and/or investigator -initiated clinical trials in accordance with trial protocols, Food and ... Drug Administration (FDA) regulations, and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) Guidelines to meet study-specific goals and timelines as well as assist the study team with the operational needs of specific protocols to… more
- BayCare Health System (Clearwater, FL)
- …to date & audit ready + Maintain regulatory master files for industry & investigator initiated clinical trials + Aid in the development of protocol specific standard ... operation procedures, and develop & train Clinical Research Coordinators on guidelines related to consent, ethical conduct and protection of human subjects. + Must have extensive knowledge of FDA regulation and human subjects protection **BayCare offers a… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that ... audit results are communicated, and appropriate corrective actions are implemented and documented on a timely basis. + In addition, this role is responsible for establishing standards and implementing procedures to ensure that the business units quality… more
- Mayo Clinic (Jacksonville, FL)
- …will train in the research program of a Mayo Clinic principal investigator . Qualified individuals will demonstrate the potential for research as evidenced by ... their training and peer-reviewed publications and should become competitive for national research grants. Proof of English proficiency is required for J-1 Short-Term Scholars, Research Scholars, Professors, Specialists, and Student Interns sponsored by Mayo… more
- Mayo Clinic (Jacksonville, FL)
- …team. This full-time faculty position is ideal for an innovative clinician investigator committed to advancing the science of urologic oncology through discovery, ... collaboration, and education. Mayo Clinic in Florida is consistently recognized for excellence and innovation. We are proud to be ranked among the Top 15 Urology Clinics in the US by Newsweek and honored as the #1 hospital in Florida by US News & World Report.… more
- ThermoFisher Scientific (Alachua, FL)
- …independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications + Ensure study compliance for ... all medical aspects by understanding and applying all relevant SOPs and GCP + Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties + In case more than 1 physician… more