Avelawance "Lance" Phillips

• Conducted site initiation visits to ensure adherence to study protocols and regulatory standards
• Coordinated and supervised clinical trial activities, including patient enrollment, data collection, and adverse event reporting
• Collaborated with interdisciplinary teams to create and execute clinical research strategies, timelines, and budget forecasts
• Delivered training and assistance to site personnel on study protocols, data collection instruments, and regulatory requirements.

• Responsibilities included: Identifying, selecting, initiating, and closing appropriate investigational sites for clinical studies
• Conducting site management visits to ensure protocol adherence, regulatory compliance, and adherence to ICH-GCP principles
• Reporting adverse events and protocol violations promptly and ensuring proper storage and accountability of trial materials
• Reviewing site regulatory binders, performing source data verification, and completing Case Report Forms on time
• Tracking and resolving site-specific protocol-related issues and attending Investigator meetings
• Assisting in recruitment, site development, subject retention, and training new clinical research associates
• Facilitating communication between study management, site staff, and investigators
• Maintaining communication with site managers, principal investigators, and site coordinators to achieve study goals
• Assisting in creating reports and source documents, scheduling review meetings, and providing additional training sessions.

• Implemented and monitored clinical trials to ensure compliance with regulatory requirements and ICH guidelines
• Visited sites to assess qualifications, initiate studies, review data accuracy, and terminate studies as needed
  Provided regular clinical status updates to team members and project management
• Performed billable work in accordance with PRA policies, procedures, and SOPs
  Collaborated with team members to resolve project and clinical issues promptly
• Communicated site trends to the Clinical Trial Manager (CTM) and project team
  Conducted investigative site file reconciliation and ensured documentation compliance
• Conducted source document verification, retrieved Case Report Forms (CRFs), and resolved queries promptly
• Oversaw drug accountability and safety at investigative sites
  Ensured timely reporting of Serious Adverse Events (SAEs) according to project specifications
  Responded promptly to requests from investigative sites.
• Performed pre-study, closeout and interim visits to check on study activities.

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