Andrés - Clinical Site CoordinatorStudy Coordinator

Oncology enrollment. Queries resolution.. Managing study site file and required protocol documents. Upload images and Veeva data managment. CTMS, MoH documentation achievment.. ICH-GCP training for site personnel

Coordinate with ethics committees to safeguard the rights, safety and wellbeing of all research subjects and research activities. Prepare final reports, occasional manuscripts or publication, New Drug Applications (NDAs). Conducting remote site management activities. Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload. Amendments and/or deviations. Assuring that data is reported accurately and timelines are maintained.

Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate. Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study

Identifying, training/initiating and closing out study sites. Conducting remote site monitoring visits and/or targeted on-site visits as needed. Conducting remote site management activities. Managing study sites and the required protocols. Amendments and/or deviations. Assuring that data is reported accurately and timelines are maintained.

Management of clinical studies. COVID-19 Vaccine. Initiation, conduction, monitoring and closure of Phase I to IV Clinical Studies, as well as Bioequivalence and Bioavailability studies. Correspondence with the corresponding authorities (Sponsor, COFEPRIS, Ethics and Research Committee, Principal Investigator). Electronic data capture. SAE Reports

Management of clinical studies. Initiation, conduction, monitoring and closure of Phase I to IV Clinical Studies, as well as Bioequivalence and Bioavailability studies. Correspondence with the corresponding authorities (Sponsor, COFEPRIS, Ethics and Research Committee, Principal Investigator). Electronic data capture

Implementation of the quality management system for NOM-177-SSA1-1998. Clinical trials coordinator

Initiation, follow-up and closure of phase I to IV clinical studies including vaccines, COPD, Asthma

Conduction of clinical protocols in coordination with the principal investigator, laboratory, sponsor