- Bayer (Tallahassee, FL)
- …FDA guidance for distribution of scientific information; + Adherence to SOP and compliance guidelines for all external contacts; + Prepares and presents data to ... projects aligned with medical and brand strategy; including facilitating investigator -initiated research (IIR) and research site identification; + Responsible for… more
- 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 ... executes data management plans, ensuring data integrity, quality control, and compliance with all relevant regulations and ethical standards. 17. Collaborates with… more
- Otsuka America Pharmaceutical Inc. (Tallahassee, FL)
- …Advocacy Groups) before during and after congresses + Organize and facilitate investigator meetings and advisory boards in conjunction with congress + Coordinate ... teams and external vendors + In-depth understanding of industry compliance , regulatory frameworks, and ethical considerations for scientific engagement **Skills… more
- HCA Healthcare (Bradenton, FL)
- …and will also work closely and effectively with physician principal investigator (s), resident(s), fellow(s), research directors, other members of the scholarly ... in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, WebEx) required + Ensure compliance to HCA data access policy and procedures + The above statements… more
- University of Miami (Miami, FL)
- …assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. + Ensures employees are trained on ... procedures. Department Specific Functions + Work with ID Research Unit Principal Investigator and Project Directors on on-going project needs active multisite &… more
- ThermoFisher Scientific (Alachua, FL)
- …and 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… more
- Pfizer (Tampa, FL)
- …and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation ... support (DSUR, PBRER) submission disclosure deliverables and product defense. + Ensures compliance with internal SOPs and external regulatory standards. + Review IIR… more
- University of Miami (Miami, FL)
- …including case report forms, surveys, longitudinal setups, and user rights; ensure compliance with IRB and institutional requirements. + Generate and deliver reports ... track both currently enrolled as well as follow-up participants. + Organizes/schedules investigator meetings and fire service site recruitment and data collection +… more
- University of Miami (Miami, FL)
- …assets. Department Specific Functions + Work with ID Research Unit Principal Investigator and Project Directors on on-going project needs active multisite & single ... + Maintain study binders, visit schedules, and regulatory documents in compliance with institutional and sponsor requirements. + Ensure participant confidentiality… more
- AbbVie (Miami, FL)
- …but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and external collaboration management. + ... segmentation, as well as optimal resource utilization. + Responsible for compliance with applicable Corporate and Divisional Policies and Procedure, including… more