Clinical Research Associate

️Apply to: https://tinyurl.com/IncreaseRecruitment

Role description:

CRA is responsible for overseeing the conduct of clinical trials to ensure they are carried out in accordance with the study protocol, ICH-GCP guidelines, and applicable regulatory requirements. This role ensures the protection of participants' rights, safety, and well-being, while maintaining the accuracy and integrity of the clinical trial data. The CRA serves as a key liaison between the sponsor and investigator sites throughout all phases of the study.

Key Responsibilities:

• Conduct site selection and feasibility assessments
• Initiate and monitor clinical trial sites to ensure protocol compliance
• Verify source data and maintain accurate documentation
• Act as the main liaison between sponsor and investigator sites
• Manage essential study documents and ensure timely submissions
• Support audits, inspections, and regulatory reporting (e.g., to Ethics Committees and BPOM)

Qualification & Requirements:

• Bachelor's degree in Health or Life Sciences (e.g., Pharmacy, Medicine, Biology)
• Minimum of 2 years of experience in a similar role within clinical research.
• Strong knowledge of ICH-GCP and local regulatory standards (CUKB, BPOM)
• Detail-oriented, proactive, and good communication skills
• Willingness to travel for site visits