The Site Coordinator is responsible for the effective management and conduct of clinical trials under the supervision of the Principal Investigator. This role includes planning daily activities, ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP). The Site Coordinator facilitates communication between the sponsor, internal and external stakeholders, and ensures the secure collection of study data, the protection of volunteer safety, and compliance with regulatory requirements.
Key Responsibilities
- Reviewing hospital files under the supervision of the principal investigator to assist preliminary volunteer screening procedures during the recruitment period, ensure necessary permits are obtained, and help identify eligible volunteers.
- Assist study personnel who are assigned in the trial in screening volunteers deemed eligible to the trial protocol by the principal investigator (organizing volunteers, and assisting in noninvasive procedures authorized by the principal investigator).
- Organize and monitor appointments to ensure volunteer visits are performed in a timely manner.
- Prepare and remind procedures to be performed during visits to assist the principal investigator in carrying out the trial protocol (e.g., listing procedures and notifying the principal investigator or other investigators).
- Send blood samples drawn from volunteers to central or local laboratories as per the trial protocol; organize and track courier procedures; monitor laboratory reports; have the investigator review reports; file reports; inform concerned parties to take immediate action if a remarkable or abnormal finding is reported.
- Assist in recording volunteer information in reference documents (patient file, study file) of the hospital.
- Support the investigator in evaluating and endorsing documents such as laboratory results, ECG examinations, IVRS confirmations, and scales amended for the study, ensuring timely filing as required.
- Take measures to ensure an adequate supply of study materials, patient diaries, laboratory kits, and patient identification cards throughout the study.
- Complete safety notification forms for events that fulfill the definition of serious adverse events and immediately notify the sponsor and monitoring team.
Must Have
- Bachelor’s degree minimum
- Understanding of regulatory requirements and Good Clinical Practice (GCP) guidelines
- At least intermediate level English
- Ability to manage time effectively and handle multiple tasks simultaneously
- Ability to handle sensitive information ethically and professionally
Nice to Have
- Master’s or PhD degree
- Preferably a graduate in health sciences or related fields
- Ability to identify problems, develop solutions, and implement corrective actions
- Excellent verbal and written communication skills
- Strong teamwork and ability to collaborate with stakeholders
- Flexibility and ability to adapt to changing conditions
- Experience in clinical studies
What’s great in the job?
- Meaningful contribution to healthcare
- Great team in a friendly and open culture
- Collaboration with professionals (investigators, sponsors, CROs, and other stakeholders)
Certification opportunities and workshops to grow your expertise in clinical research.
Respecting your privacy is our priority.