Clinical Research Associate

Work location: 3241 Rama IV Rd., Klong Ton, Klong Toey, Bangkok
Allowances: Salary as agreed
Probationary period: 119 days

Job Description
1. Perform project management tasks with a highly qualified of designated projects in accordance with the SOPs which include: investigator/site selection, site initiation, recruitment status, managing and coordinating site related activities, collating regulatory documentation and IRB submissions, and monitoring activities (such as source data verification, drug accountability, etc.) throughout the study in accordance with the ICH GCP guidelines to ensure quality and quantity commitment.
2. Ensure that the site personnel comply with the serious adverse event reporting requirements as defined by sponsor, IRB and regulatory authorities within the specified time periods.
3. Manage assigned clinical research projects on time within budget, and in compliance with FDA and other applicable regulation, ICH-GCP guidelines and Standard Operating Procedure (SOPs).
4. Work independently to ensure consistent implementation and successful completion of clinical research activities for assigned studies.
5. Manage study drugs supplies and accountability at the study sites as well as study supplies.
6. Contribute to subject recruitment strategy
7. Review and summary clinical study expenses and pay in line with the project budget.
8. Assist in feasibility assessments and site selection for different therapeutic areas.
9. Work with Director/ Manager under pressure situation and respect teamwork
10. Role model to handle effectively the project and coaching junior staff/CRA
11. Negotiation with colleague, sponsor and investigator team per expected goal

Qualification
1. Nationality Thai
2. Minimum 3 years experience in clinical operations, particularly study monitoring.
3. Knowledge of EC submission/FDA/regulations/ICH guidelines and GCPs governing the conduct of clinical trials is desirable.
4. Ability to speak and read the language(s) used locally in the country, plus a fluency in written and spoken English.
5. Good communication skill, proactive attitude, be self starting and creative.
6. Computer literate with Microsoft office
7. Readiness to travel upcountry