Clinical Research Associate

Job Description

Qualifications

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.

Additional Information

$31/HR

6 months