Careers

Committed and dedicated to advancing our Controlled IL-12 and Sleeping Beauty platform technologies.

Clinical Project Associate

The Clinical Project Associate will be responsible for supporting clinical trial activities. He/she will have regular and frequent interactions with the internal team, Contract Research Organizations and clinical site staff to ensure effective project execution.

Essential Functions and Duties

  • Assist in site management
  • Closely monitor adherence to clinical protocols
  • Monitor/track CRO activities and review monitoring trip reports
  • Co-monitor clinical sites if applicable
  • Manage adherence to clinical study plans and enrollment and data collection timelines
  • Develop and document project-specific procedures, processes and trackers for assigned studies
  • Maintain close communications with internal staff and CROs to help coordinate study activities
  • Communicates with site staff throughout the duration of the study
  • Develop and maintain tracking systems for clinical trials
  • Provide timely and accurate reports of project status to team members
  • Develop, prepare, and distribute materials (e.g. agendas) for project meetings
  • Take and distribute meeting minutes for project meetings
  • Assist in the development of clinical trial protocol summaries, protocols, Investigator brochure and informed consent documents
  • Review regulatory and clinical documents
  • Review invoices as needed
  • Prepare and submit trial-related documents to the Trial Master File
  • Provide support as needed for other clinical studies

Skills

  • Maintain a high standard of professionalism, and confidentiality, in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively.
  • Strong written and oral communication skills and above average computer skill knowledge using Outlook, Word, Excel and PowerPoint (MS Project a plus).
  • Familiar with and comfortable reviewing clinical study-specific documentation.
  • Thorough understanding of GCP, conduct of clinical trials, and medical/scientific language.

Education & Experience

  • Bachelor’s degree (in a scientific field is preferred)
  • Must have at least three consecutive years of experience working in clinical operations.
  • CRA experience preferred. Oncology experience strongly preferred.

Working Conditions

  • Office environment
  • Minimal Travel required