Santamarina Kretowicz

Performed onsite and remote clinical monitoring in line with ICH-GCP, global SOPs, protocol requirements, and applicable regulations. Conducted SIV, IMV, and COV activities including source data review, essential document oversight, investigational product accountability support, and follow-up for AE/SAE reporting. Supported sponsor audit readiness, drafted responses to audit findings, and tracked CAPAs to closure. Onboarded newly assigned CRAs and supported site activation document collection in start-up activities.

Coordinated assigned clinical monitoring activities to assess investigational product safety and efficacy, protocol compliance, and regulatory requirements. Participated in sponsor-facing site engagement for an oncology study, focusing on enrollment progress, recruitment barriers, and mitigation/support actions. Worked with investigative sites to understand recruitment roadblocks and strengthen screening and enrollment. Prepared monitoring documentation and maintained collaborations with sites, sponsor representatives, and internal study teams.

Supported multiple open-label Phase II and Phase III studies across respiratory, ophthalmology, and oncology therapeutic areas. Conducted onsite pre-study assessments and performed site initiation, monitoring, and close-out activities per the monitoring plan. Performed site data reviews and reduced SDV, reviewed Investigator Site Files, and supported timely AE/SAE reporting and follow-up. Used IVRS/IWRS tools for investigational product accountability and maintained site relationships.

Worked on open-label Phase II and Phase III studies across respiratory, general medicine/autoimmune, and cardiology indications. Conducted onsite pre-study assessments and performed site initiation, monitoring, and close-out activities as defined in the monitoring plan. Performed 100% and reduced SDV, reviewed Investigator Site Files, and supported patient safety through accurate AE/SAE reporting and follow-up. Managed investigational product accountability support using IVRS/IWRS and collaborated with remote CRAs.

Ensured sponsor and investigator obligations were met according to applicable local regulations and ICH-GCP standards. Assisted with site qualification, trial initiation and close-out support, and instruction to site personnel on proper trial conduct. Reviewed and verified clinical trial data onsite and remotely, and provided regular site status updates to the team. Completed monitoring documentation according to SOPs and contractual requirements while supporting resolution of trial and clinical issues.