Maycon Oliveira Email & Phone Number

Followed country/regional timelines and clinical deliverables from feasibility through study close out.Developed functional tools including appropriate system set-up.Conducted internal and investigator meetings.Forecasted and reconciled clinical budget and team/time allocation.Served as owner for quality events, emerging risks and planned SOP deviations.Leaded Investigator-Sponsor Cohort Management Meeting.Provided project-specific training/guidance to clinical teams. Mediated site audit discussion/response during a top-enroller site audit.Fully dedicated to Oncologic studies (Solid tumors, Multiple Myeloma, Lung cancer; on Phases I-III).

Porto Alegre, Rio Grande Do Sul, Brazil

Beyond core activities as CRA:• Acted as a point of contact for two Institutions managing indicators(recruitment, responsiveness, data management) across more than 30 trials. Supported sites to implement Risk based Remote Monitoring during COVID-19 pandemics.• Performed 4 Data Cleanings remotely on time.

São Paulo Area, Brazil

• CAPA owner for an independent site audit for a core and extension study (same program). • Contributed to mock eTMF Audit, Sponsor’s eTMF Audit, and mock Inspection. • Managed 7 studies simultaneously, acting as the sole CRA in the country for 4 studies. • Evaluated and qualified 21 sites for studies in Oncology and Central Access Obstruction.• Performed Recruitment Booster Visits.

São Paulo Area, Brazil

• Provided training and resources to activate study conduction at sites within project deadlines.• Worked with Legal Department to ensure proper study protocol conduction/management.• Delivered visit reports in a timely manner applying critical thinking and CAPA.• Supported site activities for Interim Data Base Lock on time.• Improved site's metrics consistently.

São Paulo Area, Brazil

• Performed pre-study activities. Assessed site capabilities, staff qualification/experience, site's standard procedures, logistics and other start-up activities.• Provided training and resources to activate study conduction at sites within project deadlines.• Participated in Investigators Meeting as facilitator (Study Mitigation Plan and Recruitment Strategy).• Created rapport with Principal Investigators to ensure oversight with documental evidence.• Developed and implemented actions for patient recruitment and retention.• Reviewed paper and electronic source documentation under ALCOA+ definition and verified conformity to the Case Report Forms. Evaluated, systematically, electronic system for electronic data.• Supported site activities for Interim Data Base Lock on time.• Processed Report for Endpoints (adjudication) and Serious Adverse Events.• Carried out several monitoring visits applying Risk Based Evaluation.• Delivered visit reports in a timely manner applying critical thinking and CAPA.• Addressed and followed monitoring findings, including protocol deviations.• Improved site's metrics • Assessed Investigational Product accountability, dispensing, compliance and related interventions.• Facilitated Supply Shipments and Return, including Investigational Product.• Performed Investigational Site File Reconciliation and Quality Control.• Mentored junior level CRAs.• Performed close-out activities for CRA transfer.

São Paulo Y Alrededores, Brasil

• Performed Initiation, Monitoring and Close-out Visits. • Developed Recruitment Strategy Plan (site level).• Reviewed and verified Source Documentation.• Raised and resolved queries with site staff. Performed Data Cleaning (eCRF).• Followed notification process of Serious Adverse Events.• Assessed IP accountability, dispensing and compliance.• Facilitated Investigational Product Shipments, Return and Resupply.• Ensured communication with site in a timely manner. Provided training and qualification to site staff.• Developed and improved monitoring tools.• Wrote and publicized study-country newsletters• Assessed protocol deviations trending in the country.

Guatemala

• Performed Initiation, Monitoring and Close-out Visits. • Developed Recruitment Strategy Plan (site level).• Reviewed and verified Source Documentation.• Raised and resolved queries with site staff. Performed Data Cleaning (eCRF).• Followed serious and non-serious Adverse Events documentation and notification process.• Assessed IP accountability, dispensing and compliance.• Facilitated Investigational Product Shipments, Return and Resupply.• Ensured communication with site in a timely manner. Provided training to site staff.• Developed and improved monitoring tools.

Guatemala, Costa Rica And Panama.

• Practice-based experience for the full qualification to become a CRA.• Performed Unblinded Monitoring Visits, Supplies/Drug accountability at site and country level.• Reviewed and verified Source Data.• Facilitated supplies Accountability/Returning/Destruction (including Investigational Product).*• Implemented updates in the Drug Handling Standard Operation Procedures (region level*). *Costa Rica, Guatemala and Panama.

Ribeirao Preto, Sao Paulo, Brasil.

Voluntary work for a local chapter of the largest youth run organization in the world.

Master Of Business Administration - Mba, Project Management

Pharmacy And Biochemistry