Diana Galván Bravo Email & Phone Number

León, Castilla Y León, España

León, Castilla Y León, España

- Perform feasibility studies for potential sites as requested.- Conduct pre-study, study initiation, interim monitoring and close out visits in adherence to the protocol requirements.- Conduct site visit trip report review and provide feedback and edits.- Provide mentoring and guidance to less experienced CRAs and site staff when needed.- Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate.- Design study specific tools and templates as requested.- Actively participate in study team and investigator meetings.- Create and conduct training to study team members or colleagues as requested and appropriate.- Work with Project Management to evaluate deliverables and study milestones.- Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site.- Document site visit findings via written reports.- Provide input into the design of protocols and CRFs as requested.- Assess, monitor, and train study site staff on protocol adherence as required.- Review study subject safety information and informed consent.- Conduct source document verification for compliance, patient safety, and veracity of data, including to ensure site compliance with IP receipt, accountability and return or destruction.- Review CRFs using paper or electronic data capture systems and assist sites with data query resolution.- Assist the site in maintenance of the Investigator Site File and Trial Master File (TMF).- Maintain regular communication with sites.- Audit experience: co-visit with auditor, support to the site and CAPA report elaboration.

León

- Project Management at regional level (Spain) of clinical trial with medicinal products.- Coordinating the CRA team of the project.- Contacts between the CRA and sponsor team.- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.).

León Y Alrededores, España

- Preparation and submission of human medicinal product dossier (new applications, variations and renewals).- Maintenance of medicinal product dossier.- Review updates in regulation of medicinal products, medical devices and other legal basis.- Follow-up, review and control of final texts and packaging material.- Managing main medicinal product databases and portal to manage the MAA.

- Secretary to the Board tasks: minutes of the meetings, meeting scheduling, administrative tasks.- Sciencist activities coordination and organization.- Divulgation of Biotechnology and Science.- Establishment of relationships between entities that defend and promote research and investment in Science.

Parets Del Vallès, Barcelona

Development of new hemostasis reagents.

León Y Alrededores, España

León Y Alrededores, España

Bachelor Of Science (B.Sc.) In Biotechnology, Biotechnology

Curso De Experto Profesional En Registro De Medicamentos Y Regulatory Affairs, Industria Farmacéutica

Master Of Science (M.Sc.) In Evaluation And Development Of Drugs, Speciality In Management And Production In Pharmaceutic Industry