Clinical Research Associate Ii

5 days ago

กรงเทพมหานคร, Thailand Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

**Key Responsibilities**

As a Clinical Research Associate II, you will:

- Conduct all aspects of study site monitoring, including initiation, routine visits, and close-outs.
- Manage study files and coordinate with vendors.
- Ensure study staff have the necessary materials and training to safely enroll patients.
- Monitor patient safety, informed consent procedures, and adherence to protocols.
- Verify data accuracy by reviewing source documents and identifying missing or implausible data.
- Perform site management tasks per project plans and ensure audit readiness.
- Create accurate and timely reports for each site visit.
- Support Serious Adverse Event (SAE) tracking and reporting processes.
- Assist with investigator recruitment and regulatory submissions.
- Take part in training new employees and participate in quality control visits as needed.
- Manage clinical projects as a Local Project Coordinator and act as a client contact when assigned.
- Undertake feasibility assessments when requested.

**Qualifications**

**Experience**:

- At least 2 years of clinical monitoring experience (or equivalent education/experience).
- Proficiency in monitoring study sites independently according to local regulations and SOPs.
- Experience in SAE reporting and clinical data review.

**Skills**:

- Strong planning, organizational, and problem-solving skills.
- Excellent communication and interpersonal abilities.
- Fluent in both Thai and English (spoken and written).
- Competency in using computer systems for data management.

**Education**:

- University degree or certification in a healthcare-related field (e.g., nursing) or equivalent experience.
- Comprehensive knowledge of ICH Guidelines and local regulatory requirements.

Additional Requirements:

- Ability to travel frequently, including by air.
- Valid driver's license.

**Why Join Us?**

At Fortrea, we empower our team with opportunities to make a meaningful impact on clinical research. Join a dynamic and collaborative environment that values efficiency, innovation, and personal growth.

**Fortrea is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.

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