Do you thrive in a collaborative clinical research environment where you can lead study activities and contribute to the successful delivery of impactful clinical trials?
Proclinical is seeking a Clinical Study Coordinator to manage clinical studies and related trial activities. This role involves ensuring high standards of scientific and clinical methodology, compliance with ICH-GCP guidelines, and adherence to local regulatory requirements. You will play a key role in fostering collaboration between study teams, sponsors, and CROs while mentoring and training junior team members.
Responsibilities:
- Oversee clinical trial activities from start-up to close-out, ensuring adherence to protocols and SOPs.
- Coordinate and lead study-related meetings, including Study Kick-Off and Risk Meetings.
- Ensure compliance with ICH-GCP, NHMRC guidelines, and other regulatory requirements.
- Manage Human Research Ethics Committee (HREC) processes and assist with ethics submissions as needed.
- Accurately track and manage study expenses and communicate protocol amendments.
- Organize and deliver training for study team members and the Clinical Operations team.
- Proactively identify and resolve study management issues, escalating as necessary.
- Conduct routine clinical procedures such as vitals, ECGs, and blood collection within scope of practice.
- Ensure timely follow-up on medical assessments and participant safety.
- Maintain accurate and up-to-date study documentation and databases.
- Participate in site audits, prepare responses to findings, and implement corrective actions.
- Mentor and train new team members, fostering a culture of quality and compliance.
- Contribute to the development and improvement of SOPs and operational processes.
- Pursue ongoing professional development and maintain training records.
- Comply with occupational health and safety regulations.
Key Skills & Requirements:
- Strong knowledge of ICH-GCP, NHMRC, and applicable regulatory requirements.
- Proficiency in MS Office and clinical data systems.
- Experience in clinical assessment techniques (e.g., vital signs, ECG, venepuncture) preferred.
- Excellent planning, organizational, and time management skills.
- Strong interpersonal and communication skills, with the ability to liaise across teams and stakeholders.
- Demonstrated ability to work independently and as part of a team.
- Commitment to quality, continuous learning, and improvement.
- Flexibility to adapt to changing work environments and timelines.
- Tertiary qualification in health, social, or biological sciences.
- Experience in clinical research coordination or project management, preferably in early-phase trials.
If you are having difficulty in applying or if you have any questions, please contact Sam Rodriguez at s.rodriguez@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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