Clinical Research Associate

• 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.
• 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.
• 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.
• 2-5 years of clinical research experience in 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.
• Excellent verbal and written communication skills.
• Competent computer skills including Microsoft Office.
• Familiarity with EDC systems (i.e. Oracle).