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 (<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.
- 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)
Job location: Cambridge, MA
Send CV to: email@example.com