Our Client is a Reputable Organisation looking for a Clinic Research Coordinator
Benefits
- Reputable Organisation
- AWS + Variable Bonus
- Attractive Benefits
Job Scope
- Coordinate and assist in conducting clinical research studies and trials, ensuring compliance with study protocols, applicable laws and regulations, principles, guidelines, policies, and procedures.
- Key responsibilities include:
- Screening and Recruitment: Perform screening activities based on protocol eligibility criteria and assist in recruiting participants. Help investigators explain study objectives and procedures to potential participants, and verify their eligibility before recruitment.
- Informed Consent: Obtain or assist in obtaining proper written informed consent from each study participant prior to their participation. Interact with participants to ensure study compliance.
- Protocol-Specific Activities: Complete delegated protocol-specific activities accurately and thoroughly. Schedule study visits as per protocol and ensure adherence to visit schedules. Follow up and monitor participants according to the study protocol.
- Documentation: Create source documents and other research documents required for successful conduct of a clinical research study or trial.
- Data Collection and Entry: Manage data collection accurately and in a timely manner. Obtain all necessary documentation as required by the protocol, perform data entry, and update various study-specific tracking logs. Maintain research data integrity and appropriate study documentation.
- Monitoring and Reporting: Monitor and report all adverse or unanticipated events, abnormal results, and protocol deviations or non-compliance to the Principal Investigator (PI) and Clinical Research Unit (CRU). Ensure these events are reported to funding agencies, regulatory authorities, and ethics committees as applicable.
- Audits and Monitoring Visits: Coordinate and facilitate monitoring visits and/or audits. Assist the PI in appropriate follow-up actions arising from monitoring visits and/or audits.
- Research Team Coordination: Work closely with the research team to ensure smooth coordination of research projects. Provide timely updates on study progress to team members. Regularly meet with the PI and research team members to discuss the conduct of the study and review study data.
- Regulatory and Ethics Approvals: Where applicable, assist the PI in managing regulatory and ethics approvals for assigned projects, including drafting correspondences with regulatory authorities and/or ethics committees.
Requirements
- Educational Background: Diploma or Degree Holder
- Experience: Experience in research trials and a nursing background will be advantageous.
- Knowledge: Familiarity with Good Clinical Practice, medical and research terminology, and ethics is preferred.
- Skills: Strong communication and interpersonal skills.
- Technical Proficiency: Proficient with MS Office applications.
- Work Commitment: Ability to work independently and commit to a 5.5 days' workweek.
Sun Luneng Ashley License No.: 02C3423 Personnel Registration No.: R1984277
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