Clinical Research Associate (CRA)
Division: Clinical Operations
Reporting to: Clinical Operations Manager
About the Role
Clinixir is looking for a Clinical Research Associate (CRA) to join our Clinical Operations team.
This role is designed for individuals who would like to develop their career in clinical research and gain hands-on experience in the management and monitoring of Phase I–IV clinical trials.
The Junior CRA will work closely with Clinical Research Associates (CRAs), Project Managers (PMs), Study Start-Up (SSU) and other cross-functional study team members to ensure clinical trials are conducted in compliance with ICH-GCP, applicable regulatory requirements, Sponsor requirements and Clinixir SOPs.
Key Responsibilities
- Support and perform clinical trial monitoring and site management activities across Phase I–IV clinical studies.
- Support clinical sites throughout the study lifecycle, including site selection, study initiation, monitoring and study close-out.
- Collect, track, maintain and reconcile essential study documents and Trial Master File / Investigator Site File documentation.
- Maintain study tracking systems, including study-specific trackers, monitoring tools, CTMS, ethics and regulatory documentation and site contact records.
- Provide regular site and study progress updates to the Project Manager and study team.
- Coordinate distribution and tracking of clinical trial supplies, study drugs, CRFs, Investigator Brochures, protocols and laboratory kits.
- Prepare and coordinate study-related documentation, including regulatory and site essential documents, using appropriate version control and document tracking.
- Support Ethics Committee and Regulatory Authority submissions in collaboration with the study team.
- Support tracking and reporting of Serious Adverse Events (SAEs) and other safety information according to applicable requirements and the Clinical Monitoring Plan.
- Review clinical trial data and source documentation to ensure accuracy, completeness and protocol compliance.
- Support the review of patient eligibility, informed consent, protocol compliance and investigational product accountability.
- Assist with resolution and follow-up of data queries and site-related issues.
- Review site files to ensure required documentation is complete, accurate and maintained appropriately.
- Support site budget and Clinical Trial Agreement (CTA) processes.
- Provide in-house support to CRAs and Project Managers, including communication with investigators and study coordinators.
- Participate in Investigator Meetings, Sponsor meetings, internal project meetings and other company activities as required.
- Complete all required training and maintain appropriate training documentation.
Clinical Monitoring Activities
Depending on experience, project requirements and Sponsor agreement, the Junior CRA may participate in monitoring visits under the guidance and supervision of an experienced CRA, Project Manager or Line Manager.
Monitoring activities may include:
- Site Selection / Feasibility Visits
- Site Initiation Visits
- Interim Monitoring Visits
- Close-Out Visits
- Source Data Review / Source Data Verification
- Patient safety and eligibility review
- Investigational Product accountability and reconciliation
- Site documentation review
- Follow-up of protocol deviations, data queries and site issues
What You Will Develop
This position provides an opportunity to build practical experience in:
- Clinical trial monitoring
- Site management
- ICH-GCP and regulatory compliance
- Clinical trial documentation
- Patient safety oversight
- Clinical data review
- Investigational product management
- Ethics and regulatory submissions
- Cross-functional clinical project management
Travel Requirement
Extensive travel is required and may exceed 70%, depending on project and site assignments.
If you are interested in building your career in clinical research and developing toward becoming an independent Clinical Research Associate, we would be pleased to hear from you.
Qualifications
- Bachelor's degree or higher in Pharmacy, Nursing, Medical Technology, Biological Sciences, Life Sciences, Public Health, or other related healthcare/science fields.
- 0–2 years of experience in clinical research, clinical trials, pharmaceutical, healthcare, or related fields. Fresh graduates with strong interest in clinical research are welcome to apply.
- Basic knowledge of clinical research, ICH-GCP, and the clinical trial process is an advantage.
- Good command of written and spoken English and Thai.
- Good communication, coordination, and interpersonal skills, with the ability to work effectively with investigators, study sites, sponsors, and cross-functional teams.
- Strong attention to detail, organizational skills, and the ability to manage multiple tasks and timelines.
- Proficient in Microsoft Office and comfortable working with clinical trial documentation and electronic systems.
- Proactive, responsible, eager to learn, and able to work both independently and as part of a team.
- Able and willing to travel extensively (more than 70%) according to project requirements.
- Having a valid driving license and ability to travel to study sites is an advantage.
