ThaiNGO

Job Vacancy Announcement

Study Monitor (RE-POST)

Work location: Bangkok, with frequent travel to project sites

Application deadline: 20 August 2023

Job start: as soon as possible

Background:

Dreamlopments (DLP) is a Thailand-based social enterprise and foundation working on aid and development for underserved communities. DLP is running a large project/study of community-based testing and treatment of HIV and hepatitis C (HCV) for people who use/inject drugs (PWID) in Thailand. The C-FREE study is being conducted by a large consortium of Thai NGOS, research institutes, academic experts, government officials and international partners. The project design includes a cohort study, and an HCV treatment study for participants with chronic hepatitis C. It currently takes place in Bangkok, Chiang Mai, Songkhla, Narathiwat, Tak, Khon Kaen. The research sites currently include 8 “drop-in-centers” (DIC) run by local NGOs. Partner hospitals participate in the study implementation. C-FREE was initiated in May 2019, and will close in 2023, to transition to a continuation protocol titled C-FREE-CSEA.

Job overview:

We are looking for a Study Monitor (SM) to continuously assess the quality and integrity of the study, its data collection and procedures. The SM will support the close out of C-FREE, and the initiation and conduct of C-FREE-CSEA. He/she will be in charge of monitoring C-FREE-CSEA in accordance with Good Clinical Practices, the study protocol approved by ethics committees, standard operating procedures set by Dreamlopments Foundation, and Thai FDA regulatory requirements. The SM works closely with principal investigators and the study teams, with and under the Senior Study Coordinator.

Main tasks and responsibilities:

• Support the activities of close-out of the C-FREE study, at the different study sites.
• Support the initiation of C-FREE-CSEA at the sites.
• Coordinate the overall monitoring plan and activities of C-FREE-CSEA study.
• Be responsible for conducting monitoring visits/activities at the different study sites throughout the study duration, through a mix of on-site or remote monitoring activities, as needed. 
• As part of monitoring, verify in particular data quality and completeness, alignment of data collected in source documents versus electronic case report forms, resolution of data queries from the data management center.
• Verify also that the rights and well-being of study participants are protected, through proper completion of processes related to obtaining informed consents for participation.
• Document monitoring activities and findings in writing, using Dreamlopment monitoring report formats, and communicate such findings, and any serious deficiencies noted during monitoring to the appropriate parties.
• Works cooperatively with study site staff and investigators to address their concerns and to communicate findings that can lead to improved study performance and/or compliance.
• Assist in managing ethics and regulatory authority applications and approvals, as applicable to C-FREE.
• Performs other tasks as assigned.

Qualifications required:

Education:

• University degree in nursing or biological sciences, pharmacy, public health or other related fields.

Work Experience: 

• A minimum of two (2) years’ experience in clinical study monitoring.
• Experience working in studies on HIV or viral hepatitis or other infectious diseases, a plus.

Skills and competencies: 

• Good knowledge of clinical trial monitoring procedures, medical terms, and ICH/GCP guidelines.
• Good knowledge of research quality assurance and quality control management.
• Positive attitude towards people who use drugs. 
• Interest in the C-FREE study objectives.
• Strong communication and interpersonal skills, along with the ability to work effectively as a member of an international, multi-disciplinary team.
• Proven organizational and time management skills with a strong attention to detail.
• Ability to operate with some degree of independence.
• Good sense of initiative, and problem-solving skills.
• Demonstrated ability to use standard office equipment and software, including MS Office.
• Fluent speaking /reading / writing English and Thai required.
• Thai Nationality.

Working Environment: 

• The position is attached to Bangkok head office, but requires important travel to/presence in all study sites, estimated at up to 40-50% of working time.

How to Apply: Please send a cover letter and most recent CV in English to: jobs@dreamlopments.com

Dreamlopments is an equal opportunity employer