Job Description

OverviewThe key role of the position would be to manage compliance check and conduct monitoring of Investigator Initiated Studies/Trials primarily within NUH and NUHS institutions (if necessary). The check is to ensure that Principal Investigator and their study teams are compliant with regulatory guidelines, ethics committee requirements and institutional policies.Responsibilities * Conduct Monitoring Visits

• Ensure that the coordination of monitoring visits to trials/studies that are assigned to are initiated in accordance with NUHS Research Office\'s monitoring framework.
• Provide guidance to Principal Investigator (PI) and study team to ensure that the study conduct is managed in alignment with the ethics and regulatory (if any) approved protocol and institution policies.
• Generates the monitoring visit reports within the stipulated timelines set by the NUHS Research Office\'s Monitoring Visit Work Instructions.
• Provide guidance to PI and study team in reporting non-compliance if any was detected during the monitoring visit.
• Ensure that the reporting is done in a timely manner as per the required timelines set by institution, ethics committee and regulatory.
• Provides attention to details while executing monitoring visits. This is critical to assess the quality and integrity of the study being monitored.

• Conduct research data governance audits

• Provide guidance to PI and study team to ensure research data collected is managed in alignment with the ethics approved protocol and institution data policies.
• Conduct on average 2 audits monthly with the generation of the visit report within 14 working days. To also provide the study team with timely advice on remedial action to be taken to address lapses in data management.

• Conduct Risk Assessment for Clinical Trials

• Ensure that the safety and its management are described adequately in the ethics application/protocol.
• Provide an assessment to guide the NUHS Research Office team in the recommendation for endorsement.
• Provide safety inputs and justifications if the assessment requires the Principal Investigator (PI) to form a Data Safety Monitoring Committee.

• Research Education

• Ensure that the PI and study team are adequately trained and are familiar with ICH-GCP requirements, CITI training programme and institutional policies.
• Provide inputs in the development of training materials for Clinical Research Coordinator training.
• Provides commitment and participates in the CRC training activity.

• Oversight of the NGEMR activities for research in NUH

• Ensure that applicable guides/policies are developed to manage the research component on NGEMR platform.
• Ensure that research personnel are adequately trained in managing the NGEMR platform (for research).

• Manage Data Verification

• Ensure that the research data is collected is in accordance with the ethics and regulatory (if any) approved protocol.
• Ensure that the research data is managed in compliance with institution data governance policies.

• Communication

• Ensure that good communication with all parties involved in a trial/study is in place.
• Ensure that trust and support to study team leads in the effective management of research sites. This is beneficial to monitor in managing trial/study compliance, productivity, and collaboration in order to improve trial/study related outcomes.

• Others

• Support the Research Office Director and Managers as assigned or ad-hoc, including providing administrative support with research proposal submissions, co-review of research non-compliances and related administrative or logistical duties.

• Good Degree in Life Sciences or related field.
• Have at least 1 to 3 years relevant experience in research management/administration or related industry experience - particularly in compliance related matters (knowledge of scientific principles and protocol design).
• Strong problem-solving and good communication skills (verbal and written), and ability to adapt to fast-moving situations, are required in order to manage interactions with researchers, study teams and management.
• Experience in data management will be an advantage.
• Team player.
• Understanding of research regulations and review board requirements.
• Detail orientated.

National University Health System