Clinical Research Associate (CRO -Healthcare)

About the Company

The biggest opportunity in the first research organization by Thai startups. Clinixir looking for outstanding candidates to be a part in building and driving CRO to grow globally.

Responsibilities

• Perform monitoring and site management activities for Phase I-IV clinical research projects (on site or remotely) to assess progress at assigned investigative/physician sites and ensure projects are conducted, recorded and reported per protocol, Clinixir and Sponsor SOPs, ICH-GCP and applicable local/federal regulations.
• Manage study site activities to ensure integrity of clinical data in adherence to regulatory guidelines and SOPs.
• In collaboration with study team (CRAs, SSU, PM), collect, track, maintain and reconcile essential documents and study trial files per ICH-GCP, local guidelines and Clinixir/Sponsor SOPs.
• Set up and maintain tracking systems to monitor study progress as designated by the PM (study-specific tracking tools, monitoring tools, CTMS, ethics and regulatory documents, contact records).
• Provide written and verbal site updates on study progress to the PM according to study requirements and timelines.
• Coordinate distribution and tracking of study supplies to clinical sites (study drug, CRFs, IBs, protocols, lab kits) per study requirements.
• Draft site essential documents from templates (e.g., Form FDA 1572, Financial Disclosure Forms, Contracts) using version control; coordinate circulation for review and approval; ensure Sponsor and investigator obligations meet local regulatory requirements and ICH-GCP.
• Coordinate printing and distribution of protocols, Investigator Brochures and Safety Reports for ethics/regulatory submission as requested.
• Under guidance and in collaboration with the study team, track reporting of SAEs to relevant stakeholders (Regulatory Authorities, Investigators, Sponsor) per the clinical monitoring plan.
• Implement and monitor clinical trials to ensure sponsor and investigator obligations are met and compliant with local regulatory requirements and ICH-GCP. Specific duties include site selection (feasibility), ethics & regulatory submission support, study initiation, monitoring visits, patient safety oversight, data collection and verification, site documentation review, investigational material accountability, and study close-out & archiving.
• Understand project scope, budgets and timelines for own and others' activities; manage site-level activities and communication to meet project objectives, deliverables and timelines.
• Attend Investigator Meetings and sponsor meetings; participate in and may lead global clinical monitoring/project staff meetings and clinical training sessions as required.
• Escalate site and trial related issues per Clinixir SOPs until resolved or closed.
• Provide in-house support for submission of regulatory packages to ethics committees and/or competent authorities, and for site budget and clinical trial agreement (CTA) processes.
• Perform other administrative support duties as assigned and participate in Clinixir company activities, including presentations at internal meetings.
• Ensure all required training is completed and documented and evaluate compliance with Clinixir systems and processes.

Qualifications

• Undergraduate degree or international equivalent in clinical sciences or health-related field such as BSc. in Pharmacy.

Additional Information

• Work arrangement: onsite.
• Employment type: full time.
• Extensive travel may be required (more than 75%).