Janelle Anderson

About Janelle Anderson

Connect with me on LinkedIn using a••••••••@gmail.com.I have over 27 years of visible achievements in numerous concentrations such as ophthalmology, oncology, CNS, pain, inflammation, internal medicine, infectious disease, pain management, Batten’s Disease and women\'s health. I have combined resourcefulness and problem-solving skills with clinical knowledge to consistently deliver improved research and production results. I am dedicated to helping sites initiate clinical trials while helping co-workers improve research in terms of quality, knowledge and bottom-line objectives. I am very thorough in documentation of site evaluation, GCP\'s and protocol compliance.

Experience

1. Senior Clinical Trial Leader

   Allucent

   Jan 2021 — Present

   Manage and provide leadership for all clinical monitoring activities, budgets/contractual terms, Monitoring Plan and Key Performance Indicators. Identify and escalate out of scope activities. Develop and write MP, provide training on MP and oversee CRA compliance with MP. Assist team members in identifying/selecting/recommending PIs. Oversee and lead the conduct of on-site qualification, initiation, interim monitoring and study closeout visits for studies in accordance with federal regulations, GCPs, ICH\'s, SOPs, MP and business processes, which is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures. Generate, review, approve and distribute monitoring reports and site follow-up letters. Ensure delivery timelines are met. Develop training materials, logs, tools and forms. Train CRA team as necessary. Conduct study planning, managing and troubleshooting and ensure appropriate escalation of issues. Manage enrollment issues, resolution of data queries and site performance issues. Collect and validate study data, metrics and Trial Master File. Track supply inventory, site enrollment, data queries, SAEs, project training and resolutions. Manage the preparation of clinical sites for client and internal audits and regulatory agent inspections. Ensure compliance with regulatory requirements, GCPs, company and client policies and procedures. Monitor and implement QA activities within the SMC. Mentor junior CRAs by sharing best practices/knowledge. Provide constructive feedback and adapt mentoring approach to meet the style/need of individuals. Maintain compliance with CTMS and administrative functions. Develop clinical reports, SOP revisions and document quality control. Represent Clinical Monitoring and present at client and team meetings. Perform Quality Assessment Visits or CRA Transition visits with CRAs as needed.

Education

• University of Phoenix

  Masters program, Business Administration

  2005 — 2007

• Southern Illinois University, Carbondale

  BA, Administration of Justice

  1997 — 1999

• Southern Illinois University, Carbondale

  Studied Unclassified Graduate Psychology

  1999 — 2001

• Southern Illinois University, Carbondale

  Studied Unclassified Graduate Administration of Justice

  1999 — 2001

• Southern Illinois University, Carbondale

  BA, Psychology

  1997 — 1999

Skills

• Business Strategy
• Change Management
• Organizational Development
• Documentation
• Team Leadership
• Gcp
• Pharmaceutical Industry
• Sop
• Fda
• Software Documentation
• Therapeutic Areas
• Ctms
• Regulatory Submissions
• Leadership
• Time Management
• Quality Assurance
• Ich-Gcp
• Patient Recruitment
• Contract Negotiation
• Fast Learner
• Good Clinical Practice (Gcp)
• Infectious Diseases
• Research
• Clinical Trials
• Clinical Monitoring
• Healthcare
• Irb
• Coaching
• CRO
• People Management
• Regulatory Affairs
• Customer Service
• Management
• Protocol
• Strategic Planning
• Employee Relations
• Clinical Trial Management
• Ophthalmology
• Innovation
• Clinical Research