Clinical Research Associate

Primary Role

The Clinical Research Associate (CRA) actively participates in a variety of activities to support and facilitate the efficient conduct of patient trials in our clinical research programs.

Responsibilities

  • Participation in the evaluation of clinical trial site locations.
  • Serving as the sponsor liaison to clinical sites during the activation process, as the study progresses, and during study close-out.
  • Traveling to sites as necessary to conduct site qualification, initiation, and close-out (<10%).
  • Collecting and managing regulatory documentation, to ensure compliance with GCP, ICH, regulatory authority, and ethics board requirements.
  • Working with clinical site staff and investigators to obtain study data, ensure protocol compliance, and guarantee patient safety.
  • Ensuring accurate and timely reporting of patient safety issues according to all relevant local and federal requirements.
  • Participating in regional and global conference calls and meetings to review progress of ongoing clinical trials.
  • Reviewing incoming clinical data, and preparing reports and presentations on the status of clinical studies.
  • Helping to draft study manuals and protocol amendments as needed.
  • Organizing and distributing study supplies and study-related documentation required for conduct of clinical trials.
  • Coordinating the movement of laboratory samples between clinical sites and central laboratories, and tracking the status of samples and resulting laboratory data.

Requirements

  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
  • 0-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
  • Knowledge of clinical trial methodology as well as the drug research and development process
  • Knowledge of GCP/ICH Guidelines for clinical studies
  • Ability to work independently and take initiative in a fast-paced work environment
  • Strong attention to detail
  • Strong organizational and communication skills
  • Excellent verbal and written communication skills
  • Competent computer skills including Microsoft Office
  • Familiarity with EDC systems (i.e. Oracle)

Additional Details:

Job location: Cambridge, MA

Send CV to: hr@bostonbiomedical.com