Clinical Research Co-ordinator

National Healthcare Group Polyclinics; Santo Niño 1st; On-site; PHP 240,000 - 420,000; Full time

Job summary

National Healthcare Group Polyclinics is seeking a clinical research professional to support the conduct of studies within NHG Polyclinics, ensuring compliance with study protocols, applicable laws and ethical guidelines.

The role involves screening candidates, obtaining informed consent, scheduling visits, managing data and study documents, coordinating monitoring visits and audits, and collaborating with investigators and the CRU to advance multiple research projects.

Responsibilities

• Screen participants according to protocol eligibility criteria and assist in recruitment.
• Explain study objectives and procedures to potential participants and verify eligibility before recruitment.
• Obtain informed consent from participants prior to participation and ensure participant compliance.
• Create and maintain source documents and study-related tracking logs; manage data collection and data entry.
• Coordinate monitoring visits and audits; assist PI with follow-up actions and regulatory communications.
• Collaborate with the research team to discuss study conduct and review data; assist in regulatory and ethics approvals as applicable.

Job description

Company description:

National Healthcare Group Polyclinics

Job description:

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:

• 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.
• 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.
• 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.
• Create source documents and any other research documents required for the successful conduct of a clinical research study or trial.
• 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.
• 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.
• Coordinate and facilitate monitoring visits and/or audits. Assist PI in appropriate follow-up actions arising from the monitoring visits and/or audits.
• 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.
• 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:

• 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.
• Manage approved study budget, where applicable, including tracking the utilization of budget and financial payment.
• Oversee coordination of studies with multiple sites and collaborators, where applicable.
• Assist to monitor progress of study and coordinate regular reviews with the study team and CRU.
• Assist PI in preparation of study-related presentations/materials.
• Participate in the evaluation of research results where required.