Perform all aspects of in-house site management in accordance with Good Clinical Practices related to the Strat Up, Recruitment, Maintenance and Close Out period of trials;• Perform Site Contacts/Calls with study sites in accordance with study communication and monitoring plan guidelines to support the sites’ execution of their study responsibilities. Timely document completion of the site contact and discussed items in line with the project-specific instructions and ensure timely filing of this documentation in eTMF. Help follow to resolution, issues noted during site management contacts;• Operational dashboard review of CTMS/Preclarus and other internal and study specific systems (EDC, Lab portals, IWRS etc.) in ongoing basis for SMC preparation, to manage Site Health Assessment and identify/prevent any issues; • Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor;• Conduct Substantial Amendments Implementation, support with Ethics committees Notification;• Provide ongoing site trainings related to the protocol procedures, system updating, Newsletters, Substantial Amendments etc.;• Payment process management: DAR review, invoice preparation, sign documents collection from the sites and payment process finalization with Payment team;• Escalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines;• Play an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines.

Study quality control and overviewSubject enrollment and Pharmacy countability Organize meetings, take minutes and provide administrative support for investigator meetingsTrack and update study metricsSetup and maintain TMF/eTMF, documents collection and quality checkAssist in study budget and expense management, oversight the site payment and vendor paymentCoordinate on drug supply plan, provision and destruction process, trial equipment and materials plan and managementCoordinate vendors ‘activities like printing, translation and other vendors’ managementSupport the study team with distribution of site materials and equipmentsData entryIWRSCAPACreating SOPsSafety reportICF review

Desenvolvimento de polímeros (Mw 80-90% PLLA, PLC) produzidos por dupla emulsão como fármacos aplicados ao diagnóstico por imageamento (ultrassom, TC)

- Coordinator activities on clinical trials phases 1, 2, and 3 related to oncologic areas such as lung, leukemia, head, neck, liver, kidney, ovarian, cervix, and pancreas.All protocols have been related to chemotherapy (monoclonal antibody), chemotherapy + radiotherapy associated or not cirurgy.- Development of several tools, including safety control tools, study drug/clinical materials control spreadsheets, window protocol visit spreadsheet- Performing of Drug accountability, drug supplies managing (including storage condition, temperature log evaluation and batch/expiration controlling), Follow up of drug safety issues and safety reports- Management of all Research Clinical Supplies at Pharma Department, including Study Medication, Laboratory kits, equipment etc.- Importation and exportation process of all Clinical Supplies for Brazil, including laboratory supplies, study medication, equipment (Laptops to the sites), etc. - Trainings in ICH/GCP, appropriate regulations and SOPs. - Insertion of study information in tracking systems. - Study supplies management and accountability giving support to CRAs e.g. case report forms, diary cards, lab supplies, drug supplies as appropriate. - Study medication site retrieving and Drug destruction of used/expired medication collected from site.- Reviewing Regulatory documents at site and in-house giving support to CRAs. - Assistance the project team in the tracking and distribution of safety reports. - Coordination and reviewing of clinical document translation. - Performing the drug accountability and drug accountability records review; as well as revision of temperature logs; revision and tracking of regulatory documents such as safety reports; revision and track Discrepancy Correction Forms (DCFs)