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.
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)