Will N. Email & Phone Number

Houston, Texas, United States

Houston, Texas, United States

Coordinated Site Visits: Scheduled and conducted Site Selection, Initiation, Interim Monitoring, and Close-out Visits, ensuring smooth study execution and protocol compliance.Report Generation & Follow-up: Authored site visit reports and follow-up letters, documenting site activities, compliance, and safety issues.Study Progress Monitoring: Tracked regulatory/IRB submissions, participant enrollment, CRF completion, and data queries to ensure timely study execution and compliance.Project Updates: Provided regular project updates, highlighting study progress, milestones, and challenges.Study Materials Logistics: Coordinated delivery of investigational products, lab supplies, and study materials to/from clinical sites, ensuring on-time availability and protocol compliance.Investigational Product Inventory: Managed inventory of investigational products, ensuring proper storage, handling, and return or destruction per regulations.Investigator Meeting Support: Assisted in preparing and executing Investigator Meetings, ensuring clear communication of study objectives and compliance.Regulatory Compliance: Reviewed study documents for protocol adherence and regulatory compliance, escalating deviations or safety issues to project management.Essential Document Management: Collected and reviewed essential study documents for filing in the eTMF, ensuring audit readiness.Site Training & Support: Provided protocol training to sites, managing communication and addressing site-specific issues.Site Quality Evaluation: Assessed site practices for regulatory compliance, identifying and addressing areas for improvement.Compliance & Audit: Ensured adherence to GCP, SOPs, and regulations, participating in audit responses and quality assurance activities.Team Mentorship: Mentored junior team members, offering training, feedback, and support for professional growth.

Houston, Texas, United States

Mentored Junior CRAs: Provided guidance and mentorship to junior Clinical Research Associates (CRAs), supporting their professional development and enhancing team performance.Protocol and eCRF Development: Contributed to the development and review of clinical trial protocols and Case Report Forms (eCRFs), ensuring alignment with study objectives and regulatory standards.Clinical Trial Report Writing: Assisted in writing and editing clinical trial reports, ensuring accuracy and adherence to regulatory requirements and study findings.Cross-Functional Collaboration: Worked closely with internal teams to assess project needs, allocate resources, and define timelines for successful study execution.Vendor & Supply Management: Acted as a primary point of contact for clinical trial supplies and external vendors, coordinating logistics and ensuring timely delivery of study materials.Registry Management: Managed all aspects of registry activities in accordance with project plans, ensuring proper tracking and documentation of study participants and progress.Quality Control Visits: Conducted and followed up on Quality Control (QC) visits, ensuring adherence to protocols and addressing any identified issues to maintain study quality.Data Verification and Query Resolution: Verified CRFs/eCRFs against source data for consistency, generating and resolving data queries to maintain data integrity and accuracy.Protocol Compliance & Trial Coordination: Coordinated trial processes in strict accordance with study protocols, ICH-GCP guidelines, and SOPs, ensuring compliance at all stages of the study.Study File Management: Managed the Investigator Site File (ISF), ensuring proper documentation and timely updates in the CTMS, and kept the team informed of site status.Eligibility & Informed Consent Review: Reviewed participant eligibility criteria and ensured proper documentation of informed consent to guarantee compliance with ethical standards and regulatory requirements.

Houston, Texas, United States

• Observed studies to safeguard the continued effectiveness of the investigator, clinical site team, and facility • Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs), and local requirements • Copied, logged, and scanned supporting documentation and placed all information in client files • Reviewed clinical data, source documentation, case report forms, and investigative site regulatory files • Resolved issues with investigative sites utilizing knowledge, expertise, and problem-solving techniques • Performed all site monitoring visit activities, inclusive of all study visit types (PSSV, SIV, IMV, and COV) • Monitored clinical trials to ensure sites are meeting its enrollment goals and the study is being conducted in a manner consistent with the protocol, ICH-GCP and all applicable ethical guidelines • Ensured adherence to study timelines and budgets • Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review and monitor for missing or implausible data

Houston, Texas, United States

Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs) and local requirements • Verified data integrity and accuracy • Instructed sites on how to document and report AEs, SAEs and safety concerns • Ensured sites are continually meeting patient's safety guidelines by adhering to protocol and abiding by the inclusion/exclusion criteria for each trial • Supported the development of a subject recruitment plan • Worked closely with the Clinical Trial Manager (CTM) to ensure all monitoring activities are conducted according to study requirements• Ensured site approval and gathered all documentation prior to beginning the study • Ensured sites are continually meeting patient's safety guidelines by adhering to protocol and abiding by the inclusion/exclusion criteria for each trial