Xavier C. Email & Phone Number

Austin, Tx, Us

Austin, Texas, United States

- Oversee and ensure timely execution of food & beverage clinical trials.- Coordinate pre-study activities, site qualification, study initiation, monitoring, and close-out processes.- Develop and manage study plans, timelines, IRB approvals, and partner selection while ensuring quality and compliance.- Create and execute detailed logistics plans for each trial, including inventory and participant room management.- Identify potential risks to studies, ensure ethical conduct, and provide risk mitigation solutions.- Collaborate with R&D to maintain and update essential documents for compliance with GCP.- Lead the development of study plans, system setup, and ensure operational excellence in study deliverables.- Author, audit, and edit reports, presentations, training materials, and study documents, including IRB submissions.- Lead and improve patient recruitment and retention efforts.- Address challenges in patient recruitment at all stages to enhance participation.- Ensure the safety of research subjects and report any adverse events.- Support literature research on active ingredients.- Ensure data quality and integrity throughout the study.- Develop and manage clinical study budgets.- Perform duties independently and lead team members to meet deadlines.

- Provide exceptional customer service, ensuring a safe, positive and welcoming shopping experience- Offer expertise in product and service knowledge, assisting with pipelines, leads and driving increased sales- Facilitate seamless checkout process, assist with loading merchandise and deliveries- Maintaining accurate inventory levels through efficient restocking procedures, contributing to product availability for customers

Round Rock, Texas, United States

- Performed direct patient care and conducted research assessments for over 15 neurology clinical trials (Multiple Sclerosis, Alzheimer’s Disease, Essential Tremors)- Conducted routine research visits, assisted with the informed consent process, ensuring subjects understand the purpose and procedures of their participation. Additionally handled lab testing and analysis, monitored subject safety, and promptly reported concomitant medications and adverse events to the investigator and sponsor- Collected, recorded, and maintained research subject data accordance with trial protocols and quality standards- Managed and processed clinical research data and documents to sponsor CRM/EDC systems, adhering to protocol and regulatory guidelines- Maintained source documentation ion site-level electronic patient records system- Maintained site-level compliance and regulatory documents for the respective local and Institutional Review Board (IRB) and the FDA- Managed study team and direct reports - Provided support and training to site staff, ensuring adherence to training requirements and assisting in maintaining site readiness- for site initiation, interim, and closeout visits and regulatory audits/inspections- Served as primary contact between site investigators and sponsor clinical trial team- Communicated with adjunct medical facilities and offices for external patient assessments- Maintained site level supplies for assessments and laboratory analysis- Experience with patient recruitment, screening, transfer and close-out- Develop a team of high-performing staff- Created and maintained site level standard operating procedures

Lansdale, Pennsylvania, United States

- Executed end-to-end data management activities for over 4 oncology clinical trials, including management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock (DBL) in compliance with Good Clinical Practice, local and international regulations and standard operating procedures (SOP)- Performed data review and query resolution as needed- Created and ran reports for data entry status, query status, and query aging as needed- Communicated clinical data management metrics with study team- Reviewed and developed clinical trial documents and manuals, including Case Report Forms, Edit Checks, Data Management Plans,- Clinical Data Review Plans, eCRF Completion Guidelines, Data Flow Chart(s), Data Transfer Specifications and Import Guidelines- Participated in user acceptance testing (UAT) and quality control (QC) as needed and aided in the eCRF design- Delivered hands-on support, training and mentorship to CDMs, ensuring adherence to training requirements and facilitating the acquisition of Clinical Data Management certificates- Organized and documented team meetings for check-ins, addressing discrepancies and facilitating delegation- Experience with Electronic Data Capture systems (EDC), Oracle’s InForm, Clario, ERT, Bioclinica, Medidata, RAVE, Veeva Vault, Master Trial Files, Clinical Trial Management Systems, and other third party vendor systems- Volunteer member of the Risk-Based Data Management team and Society for Clinical Data Management (SCDM)

San Angelo, Texas, United States

Official member and volunteer for the local NAACP chapter, unit 6219. Serving as on the board for the local health committee and youth organization.

Boulder, Co

- Co-founder, Men of Excellence Mentoring Program: Successfully launched a mentoring program designed to empower underserved undergraduate students. Leveraging strategic planning, spearheadeding recruitment efforts, leading to an increase in programparticipation by fostering a collaborative team environment- Delegated tasks effectively and facilitated open communication to ensure program implementation- Provided students with guidance through academic and personal challenges, fostering a supportive community that demonstrably improved student success, leading to an increase in student retention- Marketing Strategist, Signature Events & Community Development: Increased event attendance/participation through strategic digital marketing campaigns for signature events and community initiatives- Analyzed campaign performance metrics to refine strategies and optimize outreach- Collaborated with cross-functional teams to prioritize marketing efforts and allocate resources, influencing decisions to optimize outreach and engagement. Designed compelling content to drive interest and participation in organizational events, employing a creative approach to problem-solving in complex marketing environments- Assisted with program budgeting and event management- Liaison, First-Generation Scholarship Program: Developed and delivered career workshops, leadership sessions, and curated academic resources, addressing individual student needs and challenges- Partnered with stakeholders to create engaging curriculum presentations, initiatives, and relevant activities aligned with program goals and student feedback- Fostered a welcoming and inclusive community by promoting respect and utilizing conflict resolution and facilitation skills to address challenges

Integrated Remote In-Situ Sensing

To report on-field studies for the unmanned aircraft system research program, under the Grand Challenge Grant. Implementing web development and marketing strategies to promote multi-disciplinary research for government and industry leading projects.

Greater Denver Area

Facilitator for the boys2MEN Leadership Summit and organizer for the #SaveAThousand initiative. Providing mentorship and hosting a series of workshops that aids in the development of young men’s mental health, financial literacy, and interpersonal identity.

Bachelor Of Arts - Ba

Bachelor Of Science - Bs