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.

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.
• 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.

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.

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.

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