Position Tittle: Clinical Trial Monitor
Reports to: Senior Clinical Trial Monitor
The post holder participates in the preparation and execution of clinical HIV and non-HIV research studies. Support to oversee the progress of clinical investigations by conducting site evaluation, initiation, and close out visits. Monitors clinical trials in accordance with Good Clinical Practices and standard operating procedures set by PREVENTION. Works closely with principal investigators and study team to ensure all monitoring activities are conducted according to study requirements. Supervises a team of Senior Clinical Trial Monitors and delegates tasks to clinical trial team members according to required research studies. Ensures quality of work related to clinical research activities.
- Coordinating with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects
- Managing regulatory authority applications and approvals that oversee the research of new and existing drugs
- Identifying and assessing the suitability of facilities to be used as the clinical trial site
- Monitoring the trial throughout its duration, which involves visiting the trial sites on a regular basis
- Verifying that the investigator follows the approved protocol and all approved amendment, if any.
- Verifying that written informed consent was obtained before each subject's participation in the trial.
- Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement.
- Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial.
- Verifying that the investigator and the investigator's trial staff are performing the specified trial functions, in accordance with the protocol and any other written agreement between the sponsor and the investigator/institution, and have not delegated these functions to unauthorized individuals.
- Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained.
- Verifying that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial.
- Quality Assurance and Quality Control is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, SSP, GCP, and the applicable regulatory requirement.
- Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
- Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained, and initialed by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented.
- Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).
- Determining whether the investigator is maintaining the essential documents.
- Communicating deviations from the protocol, SSP, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.
- Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification.
- Collecting completed CRFs from clinical sites/community sites and general practices.
- Other tasks as assigned by supervisor.
- Thai national
- Master degree in Nursing, Biological Science, Pharmacy, Public Health or other related fields
- Minimum of 5-7 years of experience in monitoring clinical studies, especially HIV/AIDS and other relevant diseases
- Possess the ability to work independently and in a team environment.
- Good management skills, project management, organizational, and communication skills (written and verbal) in Thai and English
- Expertise in and good working knowledge of core systems and tools
- Proficient in the use of core trial management systems.
- Possess an excellent working knowledge of all applicable ICH/GCP regulations
Please send your full CV, expected salary and recent photo by 15 Aug. 2018
Human Resource Officer. If you want further information related to this position, please contact us via e-mail or phone: 02 252 9958 Only short-list candidates will be notified