The Clinical Research Associate at Company is offering the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with medical and/or health/life science interest and background who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!
Our successful Clinical Research Associates possess varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include:
- Pharmacy Technicians
- Pharmaceutical/Device Sales Representatives
- Biotech Engineers
- PhD/Pharm.D candidates
- Health and Wellness Coordinators
- Research Assistants.
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Medical device and/or investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Minimum of a bachelor's degree; Health or life science related field preferred;
- Willing to travel approximately 60-80% nationally;
- Familiarity with Microsoft® Office; and
- Strong communication and presentation skills a plus.
Song Zhao Hui EA License No. 02C3423 Personnel Registration No. R1761205