Clinical Study Coordinator

Be the Heartbeat of Clinical Research

Join our client to assist in turning innovative science into life-changing care. This role supports the coordination of clinical studies and related trial activities, ensuring compliance with scientific and clinical methodologies, regulatory requirements, and company policies. You will play a key role in facilitating collaboration between sponsors, Contract Research Organizations (CROs), and study teams to meet project goals effectively.

Key Responsibilities

• Coordinate clinical trial activities from start-up to close-out, ensuring adherence to protocols and SOPs.
• Organize and lead study-related meetings, such as Study Kick-Off and Risk Meetings, with senior staff support.
• Ensure compliance with ICH GCP, company SOPs, and local regulatory requirements.
• Support the Human Research Ethics Committee (HREC) process and assist with ethics submissions when required.
• Identify and report quality issues, collaborating with the Quality team to resolve them.
• Manage study expenses, ensuring accurate and timely billing per Clinical Trial Research Agreements (CTRA).
• Organize and deliver study-related training for team members.
• Conduct routine clinical procedures during screening, such as vitals, ECGs, and blood collection, within the scope of practice.
• Ensure participant safety through timely follow-ups on medical assessments and escalation of anomalies.
• Contribute to continuous improvement by assisting in the development and review of SOPs.
• Participate in site audits and assist with responses to audit findings.
• Maintain accurate and up-to-date study documentation and databases.
• Ensure timely data entry, e-CRF completion, and query resolution.
• Pursue ongoing professional development and maintain current training records.
• Comply with all occupational health and safety regulations and policies.

Skills and Requirements

• Strong organizational and interpersonal skills with the ability to communicate effectively with stakeholders.
• Flexibility and adaptability to changing work environments and schedules, including early mornings, evenings, or weekends as needed.
• Commitment to quality, attention to detail, and continuous learning.
• Proficiency in MS Office applications.
• Knowledge of ICH GCP principles.
• Experience in clinical research study coordination.
• Preferred but not essential: experience in clinical assessment techniques such as vital signs, ECG, and blood collection.
• Willingness to acquire additional clinical skills, such as performing 12-lead ECGs, vital signs, and basic CPR.
• A tertiary qualification in science, preferably in biochemistry, molecular biology, medical science, or related life sciences.