Clinical Research Associate needs 2-5 years of clinical research experience in industry settings with a bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
Clinical Research Associate requires;
- oncology experience strongly preferred
- EDC systems
- Knowledge of clinical trial methodology as well as the drug research and development process
- Knowledge of GCP/ICH Guidelines for clinical studies
- ORACLE
- CLINICAL TRIALS
- CLINICAL MONITORING
Clinical Research Associate duties are:
- 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.
$31/HR
6 months
