Job Vacancy Announcement – Study Coordinator, C-FREE Study

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Organization : Dreamlopments Ltd,

Job Vacancy Announcement – Study Coordinator, C-FREE Study

Work location: Bangkok, Thailand.

Application deadline: 18 October 2019.

Job start: As soon as possible.

Reports to: The General Director (GD)/Principle Investigator (PI) and the Director of Research and Advocacy (DRA)/Protocol Chair (PC).

Background: Dreamlopments Ltd (DLP) is a Thai-based social enterprise, conducting a large study of community-based testing and treatment of HIV and hepatitis C (HCV) for people who use drugs (PWUD) and their partners, called “C-FREE Study”. The study involves a large consortium of Thai NGOs, research institutes, academic experts, government officials and international partners. The study design includes a cohort study, and an HCV treatment trial for participants with hepatitis C. It takes place in Bangkok, Songhkla and Narathiwat. The research sites include 5 “drop-in-centers” (DIC) run by the local partner NGOs (Ozone and Raks Thai Foundation (RTF)), and 5 partner hospitals/research centers. Recruitment is ongoing at all DIC study sites.

Job overview: We are looking for an experienced Study Coordinator (SC) to coordinate the implementation of the study, follow and support its progress, ensure that it is conducted in accordance with the study protocol and the principles of Good Clinical Practice (GCP). To this aim, the SC works closely with all study partners, and in close collaboration with the personnel at the study sites. The SC directly supervises, with the GD and the DRA, the research nurses of each study site.

Main tasks and responsibilities:

Coordinate all aspects pertaining to the process of submission, review, and approval of the study by Ethical Committees (ECs).
Supports processes of study drug importation with the Thai FDA, import agent, customs, couriers.
Coordinates the production/update of study documents such as (and not limited to) Standard Operating Procedures (SOPs), study logbooks, forms or study-related documents.
Follow and support the progress of the study at the different study sites.
Perform overall supervision and monitoring of the study, to ensure that it is conducted according to the study protocol and the principles of GCP.
Coordinate the work of partner Clinical Research Associates (CRA) and Laboratory Specialists (LS) from FHI 360 to conduct regular monitoring and support of the study.

Assist the investigators in the process of preparation/review of Adverse Event reports, and submission to ECs.
Follow closely the consumption and accountability of study products (medicines, diagnostic tests), in collaboration with the research nurses, the CRA and LS.
Assist the PI and PC to work with the data management center on the quality of the study data, interim and final analyses.
Ensure good coordination of the study, and good communication, between the different partners: the NGOs operating the DIC (Ozone and RTF), the study investigators, the partner hospitals, and additional members of the Steering Committee.
Coordinate with the PI the preparation and conduct of study trainings, and meetings.
With the GD/DRA, supervise and assign tasks to the Senior Administrator (SA) in the support of the study.
Work with the GD/DRA, and the SA on reports to funders of the study, preparation of study budgets.
Visit study sites at regular intervals.
Other assignments as requested by the GD/DRA.

Qualifications required:

Education:

Earned Bachelor’s degree in Pharmacy, Nursing or Health Science-related courses.

Work Experience:

A minimum of five years of experience in monitoring/managing clinical research.
Possess knowledge of local regulatory requirements and ICH-GCP.
Experience in management of care/research in HIV infection and/or viral hepatitis, a strong plus.
Experience working in programs serving people who use drugs, a plus.
Experience working for non-government organizations, a plus.

Skills and competencies:

Positive attitude towards people who use drugs.
A good understanding of, and interest, in clinical research.
Ability to understand and use scientific methodology.
Interest in the C-FREE study objectives.
Excellent organizational and time management skills, with a strong attention to details.
Proficient in spoken and written English.
Have good oral & written communication skills, presentation skills, interpersonal skills.
Ability to work effectively as a member of an international, multi-disciplinary team.
Be results-oriented, flexible, have good analytical thinking and stakeholder management skills.
Be able to work independently and in a team environment, with patient-centered approach.
Demonstrated ability to use standard office equipment and software, including MS Office.
Thai Nationality.
Be able to travel up country to all study sites.