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Skills

  • Public relations
  • Pre-trial procedures mastery
  • Integrated medical reporting
  • Protocol adherence
  • Curriculum development
  • Project development
  • NDAs
  • Interactive management
  • Research and development
  • Clinical research monitoring experience

Work Experiences

  • Kept track of the collection, accuracy, and integrity of regulatory documents in the site binder.
  • Was in charge of ensuring the safety of human subjects and ensuring that consent procedures followed local and federal regulations.
  • Teamwork
  • Reviewed data queries and listings and collaborated with study centers to resolve data inconsistencies.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
  • Was in charge of patient safety and informed consent procedures.
  • Communicated important clinical data and events with process department personnel.
  • Collaborated closely with other department employees to communicate important information and maintain study integrity.
  • Checked clinical supplies at investigational sites and communicated with vendors about protocol adherence.
  • Was in charge of site monitoring and was the main point of contact for system sites.

Summaries

  • Advanced planning, problem-solving, and communication skills honed over 18+ years of successful clinical research.
  • Dedicated to learning, growing, and succeeding in Computers Software.
  • Mental health counselor who excels at leading situational counseling sessions.
  • Site qualification, initiation, monitoring, and close-out visits have all been completed successfully.
  • Initiative is an example of a specialty area.
  • Strengths in cross-functional collaboration and data analysis backed up by Computers Software training.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the metric business.
  • Within Computers Software, senior Clinical Research Associate and outstanding performer in stakeholder engagement and cross-functional collaboration.
  • Compassionate, solution-oriented Clinical Research Associate committed to providing exceptional care and developing innovative treatment plans for children, adolescents, and adults suffering from substance abuse problems.
  • Excellent communication and decision-making skills, both verbally and in writing.

Accomplishments

  • Researched
  • Administered
  • Wrote
  • Established
  • Protective Services: Applied safety procedures and policies as outlined in Department Safety Manual.
  • Design: Responsible for creative design for prominent program.
  • Discovered
  • Resolved
  • Facilitated
  • Recommended

Affiliations

  • National Association of Social Workers
  • Society for Clinical Data Management (SCDM)
  • Society of Clinical Research Associates (SOCRA)
  • Project Management Institute
  • Lions Club
  • European Clinical Research Infrastructure Network (ECRIN)
  • Association for Computing Machinery
  • American Association of Pharmaceutical Scientists (AAPS)
  • European Medicines Agency (EMA) Stakeholder Group
  • International Association of Clinical Research Nurses (IACRN)

Certifications

  • Certified Business Analysis Professional (CBAP)
  • Human Subjects Protection (HSP) Certification - Raleigh
  • Clinical Research Associate (CRA) Professional Certification - Northwind - Seattle
  • ICH-GCP Certification – Vantage
  • CompTIA A+ Technician
  • Electronic Data Capture (EDC) Software Proficiency - Tableau
  • Clinical Research Quality Assurance (QA) Certified Professional - Harbor & Co. - 2020
  • Certified Medical Monitor (CMM) – Northwind
  • Therapeutic Area Knowledge Certification - Lakeside Partners - 2024
  • Certified Ethical Researcher (CER) - Beacon Labs

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