Study Coordinator Assistant

Job Vacancy Announcement

Study Coordinator Assistant

Work location: Bangkok, with frequent travel to project sites Application deadline: -

Job start: as soon as possible

Background:

Dreamlopments (DLP) Foundation 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) and other high-risk groups, 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, and Chiang Rai. The research sites include 9 “drop-in-centers” (DIC) run by local NGOs, and partner hospitals participate in the study implementation. Two other study sites in Pattani and Nakhon Si Thammarat will soon be added to the study. C-FREE was initiated in May 2019, and  transitioned in March 2023 as the continuation protocol titled C-FREE-CSEA.

Job overview:

We are looking for a Study Coordinator Assistant (SCA) to a) support the Senior Study Coordinator in coordinating the implementation of the study, managing clinical operations and regulatory activities, and b) to be in charge of conducting monitoring of the study. The SCA works closely with Principal Investigator (PI), and the study teams, with and under the Senior Study Coordinator.

Main tasks and responsibilities:

• • Support the activities of close-out of the initial C-FREE.
  • Assist in preparing and managing ethics and regulatory authority applications and approvals, as applicable to C-FREE-CSEA.
  • Assist in internal quality control audits of clinical study documentation (e.g. TMF, ISF, Monitoring File, etc.)
• Assist in developing new or amended study protocols, patient information sheets, informed consent forms, case report forms, standard operating procedures, or other forms and related documents.
• Support the initiation of C-FREE-CSEA at the sites.
• Follow and support the progress of the study at the different study sites.
• Follow closely the consumption and accountability of study products (medicines, diagnostic tests), in collaboration with the RN/RA, the CRA and LS.
• Participate to prepare and track orders of study supplies. 
• Coordinate the overall monitoring plan and activities of the 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, and resolution of data queries from the data management center.
  • Document monitoring activities and findings in writing, using Dreamlopments monitoring report formats, and communicate such findings and any serious deficiencies noted during monitoring to the appropriate parties.
  • Assist in the coordination with the Data Management Center on the quality of the study data, interim and final analyses.
  • 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.
• Other duties as assigned by supervisors.

Qualifications required:

 Education:

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

Work Experience:

• A minimum of three (3) years’ experience in clinical study monitoring, and study coordination.
• At least 1 year of independent monitoring experience is a plus.
• 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 the most recent CV in English to jobs@dreamlopments.com .

Dreamlopments is an equal opportunity employer.

Comments