Clinical Research Co-ordinator

National Healthcare Group Polyclinics; Singapore; Vor Ort; SGD 40.000 - 68.000; Vollzeit

Zusammenfassung

National Healthcare Group Polyclinics is seeking a capable Clinical Research Coordinator to support the conduct of clinical studies in NHG Polyclinics in compliance with study protocols, applicable laws and guidelines.

You will screen participants, obtain consent, schedule visits, manage data, monitor safety events, coordinate monitoring visits, and work with the study team to ensure timely progress.

Aufgaben

• Screen participants according to protocol eligibility criteria and assist in recruitment.
• Obtain or assist to obtain written informed consent from each participant prior to participation.
• Schedule study visits as per protocol and monitor adherence to visit schedules.
• Create source documents and other research documents required for the study.
• Manage data collection and data entry, maintaining data integrity and study documentation.
• Monitor and report adverse/unanticipated events, non-compliance, and deviations to PI and CRU.
• Coordinate and facilitate monitoring visits and audits, and follow up on actions arising from visits or audits.
• Provide updates on study progress and coordinate with the study team to discuss conduct of the study.

Jobbeschreibung

Principal Responsibilities

To coordinate and assist in the conduct of clinical research studies and trials in NHG Polyclinics in compliance with study protocols, applicable laws and regulations, principles, guidelines, policies and procedures. Responsibilities include but are not limited to:

1. Perform screening activities according to protocol eligibility criteria and assist in recruitment. Assist investigator in explaining study objectives and procedures to potential participants. Verify eligibility of participants before recruitment.

2. Obtain or assist to obtain proper written informed consent from each study participant prior to participation in the study. Interact with participants to ensure study compliance.

3. Perform delegated protocol-specific activities completely and accurately. Schedule study visits as per protocol and ensure visit schedules are adhered to. Follow up and monitor participants in accordance with study protocol.

4. Create source documents and any other research documents required for the successful conduct of a clinical research study or trial.

5. Manage data collection in an accurate and timely manner. Obtain all necessary documentation as required by the protocol and perform data entry, including updating of various study-specific tracking logs. Maintain research data integrity and appropriate study documentation.

6. Monitor and report all adverse/ unanticipated events, abnormal results, and protocol deviations or non-compliance to the Principal Investigator and CRU. Ensure these events are reported accordingly to funding agencies, regulatory authority and ethics committee as applicable.

7. Coordinate and facilitate monitoring visits and/or audits. Assist PI in appropriate follow-up actions arising from the monitoring visits and/or audits.

8. Work closely with research team for smooth coordination of research projects. Provide timely updates on study progress with study team members. Meet with the Principal Investigator and research team members regularly to discuss the conduct of the study and review study data.

1. Where applicable, assist PI in managing applicable regulatory and ethics approvals for the assigned projects, including drafting correspondences with the regulatory authority and/or ethics committee.

In addition to responsibilities stated above, to also assist in other administrative aspects and overall coordination of assigned research projects. Duties include:

1. Coordinate with study team, CRU and clinics to start up study site(s) in NHGP, including making necessary logistical arrangements, setting up investigator files, preparation for study initiation meetings/visits.

1. Manage approved study budget, where applicable, including tracking the utilization of budget and financial payment.

1. Oversee coordination of studies with multiple sites and collaborators, where applicable.

1. Assist to monitor progress of study and coordinate regular reviews with the study team and CRU.

1. Assist PI in preparation of study-related presentations/materials.

1. Participate in the evaluation of research results where required.