Pedro Mariano Email and Phone Number

•Contribute to the identification of new sites for clinical trials, analyse capability and support Clinical Research Manager (CRMA) and Clinical Study Manager (CSM) in making recommendation for trial inclusion; •Assume ambassadorial role to facilitate communication between sites and sponsor CPO to increase value proposition to investigators; •Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP; •Negotiate investigator remuneration; prepare financial contracts between sponsor and investigational sites and investigators. Ensure adherence to payment schedule; •Execute site initiation and training, generate initiation visit report; •Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes; •Identify problems at sites; resolve issues and escalate as appropriate; •Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed; •Complete preparation and generation of visit monitoring reports as per relevant SOP; •Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets; •If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues Study Close-out; •Implement site close-out activities and generate site close-out report; •Provide feedback on site performance for future trial site feasibility/selection; Highlights:•Acting as LeadCRA in 3 different projects with specific sponsor (stock management, import and export process of medication and supplies);•Training new CRAs in the mentoring model;

•Participation in classes of Clinical Research Associtate School Initiative – to promote the development of new CRAs;•Support for more than 3 new monitors in the buddy CRA model;•Participation in the IQVIA Brand Ambassador initiative in its launch until January 2022;•Performer initiation, monitoring and close-out visits for studies of different therapeutic areas;•Assistance in managing “Action Items” (issues from sites) from other CRAs with video presentation via CRO system.

•Responsible for more than 1,600 subjects on sites across Brazil for COVID studies during the pandemic, with more than 180 days on-site during the period;•Performer a monitoring and close-out visits to oncology studies.

Study Coordinator•Analysis of research projects and ensuring the protection of research subjects according to Good Clinical Practices (GCP), national and international legislation;•Application of training, continuing education programs and service meetings;•Proactive participation in investigator meetings, initiation and monitoring visits;•Maintenance of data flow through source documents, through EDC, in addition to ensuring the accuracy and reliability of data generated by the site;•Knowledge of protocol, principles and management systems for research and clinical screening;•Elaboration and immediate application of corrective actions, if necessary. This ensuring the quality of the study;•Maintenance of strategies that allow fast communication between team members and research participants.Coordination of 22 oncology studies in the therapeutic areas of lung, head and neck, prostate, and hematology.

•Laboratory technical support and research management;•Placing orders for radiology exams;•Forwarding examination reports to the central laboratory, within the period established by the sponsor;Participation in lung cancer study audit process without new queries and no critical findings.

•Propose, plan and execute research, development and technological innovation management activities;•Develop technical scientific publications, disseminating them nationally and internationally;•Develop potential scenarios for scientific and technological development, contributing to the expansion of the limit of knowledge in the specialty;•Identify and analyze problems, propose solutions, establish action plans and monitor their implementation in large interinstitutional projects.•Application in forms of learning and research, as well as participation in scientific works. In addition to the development of soft skills.