Clinical Trial Associate

Job Description

Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable, predictive computational discovery platforms to identify novel drug targets and develop first-in-class therapeutics in the field of cancer immunotherapy. Our therapeutic pipeline consists of immuno-oncology programs against novel drug targets we discovered computationally, including T cell immune checkpoints and additional early-stage immune-oncology programs including myeloid targets. As we advance our pipeline, we are looking for a senior clinical trials manager to oversee the day-to-day operations of the clinical trials.

The Clinical Trial Associate is a member of the clinical team responsible for the day to day planning, execution and management of one or multiple clinical trial(s). Responsibilities include assisting the clinical operations team, contributing to essential document tracking, reviewing of ICFs, reviewing budgets, overseeing clinical trial sites and CROs. The CTA will have cross-functional interactions with the clinical development team, clinical data management, budget, and finance, research, and development.

  • Reviews regulatory documents for accurate content
  • Performs investigator file reviews and logging of outstanding issues in project related tracking tools
  • Provides oversite of document version tracking and filing
  • Liaises with CRO and investigative sites to resolve outstanding regulatory issues
  • Disseminates study related information, including project tracking updates to clients, clinical study teams and other departments as applicable
  • Creates meeting agendas and minutes
  • Coordinates team conference calls and distribution of meeting minutes
  • Contribute to the development of clinical documents including but not limited to protocols, ICF, study manuals, lab manuals
  • Oversees essential document management during study startup, study closeouts and participates in SIV to ensure site readiness for activation
  • Familiarity with GCP/ICH and ensures that the clinical trial is conducted per these regulations and SOP
  • Contributes to the preparation of study-related budget documents and reviews study-related financial documents
  • Assist in the development and implementation of enrollment strategies

Job Requirements

  • Minimum of a bachelor’s degree in a scientific or health care discipline preferred
  • Prior experience in the pharmaceutical/biotech industry is required
  • At least 2 years experience as a Clinical Trial Associate
  • Highly effective team player with exceptional interpersonal skills building relationships with clinical trial sites
  • Ability to work independently with little oversight and attention to detail and results oriented
  • Ability to utilize critical thinking to analyze problems which may require multiple factors and approaches
  • Excellent oral and written communication skill
  • This position requires travel 20% of the time
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