Assistant Clinical Research Coordinator / Clinical Research Coordinator, Ophthalmology

National University Health System; Singapore; On-site; SGD 42,000 - 66,000; Full time

Job summary

The National University Health System seeks an Assistant Clinical Research Coordinator / Clinical Research Coordinator to support ophthalmology research, coordinating study activities and ensuring alignment with ICH GCP, HBRA and institutional policies.

You will assist with ethics submissions, feasibility, participant screening, informed consent, study visits, data management, and regulatory documentation, contributing to high-quality clinical research delivery.

Qualifications

• Bachelor's Degree or Diploma in Optometry or related health disciplines is required.
• Experience in clinical research or research coordination is advantageous.
• At least 1 year of relevant experience may qualify for the Coordinator level.
• Knowledge of ICH GCP, HBRA and local regulatory requirements is advantageous.
• Proficient with MS Office and REDCap or similar data capture tools.
• Strong written and verbal communication, with excellent interpersonal skills.

Responsibilities

• Coordinate screening, recruitment and eligibility assessment for participants.
• Explain study objectives and procedures in clear language to participants.
• Assist with informed consent and study visits scheduling and follow-up.
• Manage data collection, entry and study documentation in accordance with protocol.
• Prepare CRFs/eCRFs and maintain regulatory documentation and study files.
• Support regulatory submissions to IRB/DSRB and external bodies.
• Assist with monitoring visits, audits and inspections.
• Coordinate sample handling, labeling and transport where applicable.
• Collaborate with PIs, clinicians, and research staff to ensure protocol compliance.

Skills

Excellent communication

Verbal communication

Written communication

Meticulous

Organised

Independent working

Team collaboration

Adaptability

Education

Bachelor's Degree or Diploma in Optometry

Life Sciences

Medical Sciences

Biomedical Sciences

Nursing

Allied Health

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Teams

REDCap

EHR/Electronic records

Job description

The Assistant Clinical Research Coordinator / Clinical Research Coordinator will provide research coordination and operational support for clinical research studies within Ophthalmology, working closely with Principal Investigators (PIs), clinicians, research teams and relevant stakeholders. The role supports study activities including ethics and regulatory submissions, study set-up, participant screening and recruitment, informed consent, study visits and follow-up, data collection and management, and maintenance of study documentation. The incumbent will assist investigators in ensuring that studies are conducted in accordance with approved study protocols, ICH Good Clinical Practice (ICH GCP), the Singapore Human Biomedical Research Act (HBRA), applicable regulatory and ethical requirements, and institutional policies, while supporting ophthalmology-specific research activities and workflows where applicable.

Responsibilities

A. Clinical Research Coordination and Participant Management

• Assist investigators in the screening, identification and recruitment of potential study participants according to protocol-defined eligibility criteria.
• Explain study objectives, procedures and requirements to potential participants in clear and appropriate language.
• Assist investigators with the informed consent process and obtain informed consent where appropriately delegated and permitted.
• Coordinate and schedule study visits, investigations and follow-up appointments for study participants.
• Administer study questionnaires, conduct participant interviews and perform other protocol-specific assessments as required.
• Maintain regular follow-up with study participants and facilitate participant retention throughout the study period.
• Coordinate with investigators, clinicians, clinic staff and other relevant departments to ensure that study visits and research activities are conducted according to protocol.
• Support ophthalmology-specific clinical assessments and research procedures where applicable and within the incumbent's competency and scope of practice.
• Assist with investigational product/study drug-related activities, including dispensing, reconstitution and drug accountability, where applicable and under appropriate investigator supervision.

B. Study Operations, Data Management and Documentation

• Plan, organise and coordinate study activities and operational workflows from study initiation through study completion.
• Attend and support study initiation, monitoring, close-out and other trial-related meetings.
• Assist in the development and implementation of study workflows across relevant clinical departments.
• Conduct and coordinate research activities including participant recruitment, data collection, data entry and data management.
• Collect relevant clinical and research data from source documents and electronic health records.
• Complete Case Report Forms (CRFs) and electronic Case Report Forms (eCRFs) accurately and within required timelines.
• Maintain study databases, including REDCap and other electronic data capture systems, as applicable.
• Ensure accurate, complete and contemporaneous documentation in source documents and study records.
• Establish and maintain Investigator Site Files and other essential study documentation, ensuring records are complete, accurate and up to date.
• Maintain appropriate records of informed consent and other participant-related study documentation.
• Trace and maintain relevant laboratory, imaging and diagnostic reports as required by the study protocol.
• Coordinate the processing, labelling, storage and dispatch of biological specimens to relevant laboratories according to protocol requirements, where applicable.
• Maintain participant confidentiality and ensure appropriate handling and protection of research data.
• Prepare study documentation and records for monitoring visits, audits and regulatory inspections.
• Support study data review, data validation and analysis, where required.

C. Ethics, Regulatory and Research Governance

• Ensure study activities are conducted in accordance with the approved protocol, ICH GCP, HBRA and other applicable regulatory, ethical and institutional requirements.
• Assist investigators with the preparation and submission of new study applications to the relevant IRB/DSRB.
• Coordinate submissions of protocol amendments, study status/continuing review reports, study closure reports and other regulatory or ethics documentation.
• Assist investigators with applications and submissions to HSA for clinical trial authorisation, clinical research materials or other regulatory approvals, where applicable.
• Assist investigators with the documentation and reporting of protocol deviations, non-compliance and other reportable events to the relevant IRB/DSRB, HSA and/or sponsor, where applicable.
• Assist investigators with the documentation and reporting of adverse events and serious adverse events in accordance with protocol and regulatory requirements.
• Liaise with IRB/DSRB, HSA, sponsors, monitors and other relevant parties regarding study submissions, queries, approvals and progress updates.
• Maintain regulatory and ethics correspondence and ensure that approvals and essential documents remain current throughout the study.
• Maintain readiness for internal and external audits, monitoring visits and regulatory inspections.
• Maintain the highest standards of professional conduct, research integrity, documentation and record keeping in accordance with institutional policies and applicable regulations.

D. Research Protocol and Study Development

• Support investigators in the development and preparation of research protocols and related study documents.
• Assist with study feasibility assessment, planning and preparation of study logistics.
• Support the development and implementation of participant recruitment strategies and study workflows.
• Assist with the preparation of study materials, data collection tools, questionnaires and research databases, where applicable.
• Support data review, evaluation and analysis as required by the PI or research team.
• Contribute to continuous improvement of research processes and workflows to facilitate efficient and compliant study conduct.

E. General and Administrative Responsibilities

• Work closely with PIs, investigators, clinicians, research staff and other internal and external stakeholders to support the successful delivery of research studies.
• Monitor study timelines, recruitment progress and research deliverables and highlight potential issues to the PI or supervisor in a timely manner.
• Provide administrative and logistical support for research-related meetings and activities as required.
• Undertake other research-related, administrative or ad-hoc duties of a similar nature as assigned by the PI or supervisor.

Requirements

• Bachelor's Degree or Diploma in Optometry, Life Sciences, Medical Sciences, Biomedical Sciences, Nursing, Allied Health or other relevant healthcare-related disciplines.
• Candidates who are qualified/certified Optometrists will have an added advantage.
• Prior experience in clinical research, clinical trials or research coordination would be advantageous.
• Candidates with at least one year of relevant experience as a Research Coordinator may be considered for appointment at the Clinical Research Coordinator level, depending on qualifications and experience.
• Knowledge of ICH GCP, HBRA and applicable local clinical research regulatory and ethical requirements would be advantageous.
• Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, Outlook and Teams.
• Experience with research databases and electronic data capture systems, such as REDCap, would be advantageous.
• Excellent written and verbal communication skills.
• Effectively bilingual, with the ability to communicate study-related information to participants in an appropriate and understandable manner.
• Good interpersonal skills and ability to communicate effectively with patients, investigators, clinicians and multidisciplinary stakeholders.
• Meticulous and organised, with strong attention to detail and documentation.
• Able to prioritise and manage multiple studies, tasks and timelines concurrently.
• Able to adapt and perform effectively in a fast-paced clinical research environment, with a strong focus on meeting study deliverables and recruitment targets.
• Able to work independently with appropriate supervision, as well as collaboratively within a multidisciplinary research and clinical team.
• Demonstrates professionalism, integrity and commitment to maintaining participant confidentiality and high standards of research conduct.