Your new company
Our client, an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work globally. They are growing quickly and seeking experienced Clinical Research Associates to join their regional clinical research team.
Your new role
- 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.
What you'll need to succeed
- Experience as a Clinical Research Associate;
- Approximately 60-80% non-local, national travel is required;
- Must have a minimum of a bachelor’s degree in a health or science related field;
- Proficient knowledge of Microsoft® Office;
- Outstanding communication skills; and
- Must be detail-oriented and efficient in time management.
What you'll get in return
- Customised, expedited training
- Regional exposure, MNC culture
- Training Program
What you need to do now:
If you are interested in the above opportunity, please forward your latest resume to email@example.com or contact Flavia at +852 2230 7473 for more information. If this role isn't quite right for you, but you are looking to explore new opportunities in the life science sector, please contact Flavia for a confidential discussion about your options.