Lisa Vega

• Responsible for oversight of both site and monitoring quality, regulatory and GCP compliance.

•Drive inspection readiness and provide support for site audits/inspections as needed.

• Follow study oversight guidance and proactively put in place mitigations for known or anticipated risks.

• Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks.

• Apply knowledge of data and analytics to target site and study, recommend and implement actions

for mitigation and control.

• Conduct and report oversight activities, both remote and onsite visits.

• Perform additional oversight visits/reviews with CRAs based on the risks that arise during the course of a study to ensure audit readiness.

• Work with CROs, CRAs and other CRO colleagues as appropriate, to drive resolution to quality events.

• Review of CRA monitoring visit reports
• Conduct regular 1:1 meetings with CRAs to review oversight visit findings and/or quality events

• Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of CAPAs.

• Serve as a point of contact for quality and safety escalations for CRO, CRAs, and study team leads.

• Assisted with on-boarding and training, as well as served as a mentor to new Site Care Partners

•Assisted PRA/ICON interviewer with hiring of new SREPs/SEPs/SCPs

• Monitor and oversee investigator drug trials with both on-site and remote visits in US and Canada.
• Subject eligibility/Data Verification, Drug Accountability/ IMP dose observation, Query issuance and closure.
• Complete monitoring visit reports (MVRs) within company metrics/timelines.
• Conducts on-going site management to determine compliance and prepares/collects required documentation to ensure inspection-readiness.
• Collection of essential documents and maintenance of site ISFs and eTMF compliance.
• Responsible for multiple projects working both independently and in a team environment.
• Ensure subject safety at all times (document AE’s, SAEs) and ensure timely submissions.
• Identify, report, and escalate protocol deviations
• Act as liaison between sponsor and site.
• Collaborates with vendors (Almac/IXRS, Oracle/EDC, WCC/WorldPro, MedPace
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Implemented electronic data capturing systems to adhere with clinical research guidelines.
• Followed drug storage procedures to comply with protocols and SOP requirements.
• Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.

• Completed: Site selection, initiation, interim monitoring (on-site & remote/risk-based, and close out visits in accordance with good clinical practice.

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

• Provided both blinded & unblinded monitoring for multiple protocols, and therapeutic areas.

• Administer protocol related training to assigned sites and establish regular lines of communication to

manage ongoing project expectations and issues.

• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol

and adherence to applicable guidelines.

• Escalate site quality issues to project manager and study leads as appropriate.

• Monitor timely regulatory submissions and approvals, recruitment/enrollment case report form (CRF) completion, Data entry and timely query resolution.

• Create and maintain documentation regarding site management, visit findings, and action plans by

submitting visit reports, follow up letters and other study documents

• Performed both on-site and remote site visits (centralized) while monitoring activities in accordance with protocol,
• GCP/ICH Guidelines, and/or other applicable regulatory requirements.
• Complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required
• Evaluate overall performance of site and site staff.
• Ensure site compliance and understanding of study requirements by site contacts.
• Ensure adequate enrollment.
• Identify and escalate more complex issues.
• Interpret data to identify protocol deviations or major risks to data integrity.
• Understand and interpret protocol and regulations to ensure sites are inspection-ready.
• Assisted with sponsor audits on site and follow-up CAPA
• Understand project scope, budgets, and timelines to better provide input and manage project objectives
• Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
• Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Reviewed data queries and listings and worked with study centers to resolve data discrepancies.

• Spearheaded Department of Neurosurgery's clinical research program.
• Developed systems to track study activities. Prepared protocols, informed consents and reports.
• Coached team members on productivity strategies to accomplish challenging goals.
• Developed and maintained logistics workflows, procedures and reports.
• Managed multiple strategic projects with numerous sub-projects or workstreams.
• Collaborated with business leadership to set priorities based on business needs, resource capacity and risk exposure.
• Interacted with customers and clients to identify business needs and requirements.
• Built teams to address project goals and objectives for multiple projects.
• Prepared and reviewed all study related documents for completeness and accuracy.
• Submitted regulatory documents for IRB approval.
• Collected and maintained clinical data.
• Assisted in specimen collection/shipments per IATA guidelines.
• Attended all PSSV, SIV, f/u site and closeout visits.
• Developed budgets and allocated required resources.
• Interviewed/trained new site staff.
• Managed and supervised administrative and daily program operations, complying with policies and regulations.