Research Coordinator (Jd-0919-033)

JOB SUMMARY

The recent, impressive growth in clinical trials capacity and opportunity at OUCRU needs to be matched with high-level research governance and operation to ensure safe and high quality research in line with international standards. The post-holder, is required to execute new research projects and contribute to the continued growth and development of the CTU team.

KEY TASKS AND RESBONSIBILITIES

The post-holder will be based within the OUCRU-VN Clinical Trials Unit and have key tasks and responsibilities below:
• Maintain an up-to-date understanding of the applicable trial regulations, both local and international, train investigators on regulatory changes and ensure that these standards are implemented in all research managed by the CTU.
• Implement the Unit’s policies on the conduct of clinical trials.
• Contribute to the development of quality and efficiency within the CTU.
• Coordinate all regulatory, logistical, training and reporting tasks associated with running a clinical study/trial.
• Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.
• Be a part of a team that provides training for senior hospital staff on the ICH guidelines of Good Clinical Practice.

Key duties/tasks:
• Understand relevant clinical research protocols and regulatory requirements.
• Translate study documents (Vietnamese - English – Vietnamese).
• Develop standard operating procedures to control the quality of study conduct.
• Organize logistics of study materials including drugs, files, test kits, patient samples, data and other materials.
• Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH/GCP guidelines.
• Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment.
• Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files, maintaining patient charts and supply inventories, etc.
• Verify that data entered on to the CRFs is complete and consistent with patient clinical notes, known as source data/document verification.
• Coordinate patient visit schedule as per study protocol.
• Supervise the conduct of the study to ensure compliance with the principles of Good Clinical Practice, which will involve visiting the study sites on a regular basis.
• Track study progress and identify problems. Report to stakeholders as required.
• Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.
• Organize and participate in group meetings to share experience and contribute to the knowledge of others in the team.
• Attend career training to improve skills and update relevant knowledge.
• Other tasks as required.

DEPARTMENT
Clinical Trial Unit (CTU)

LOCATION
This post is based in OUCRU Ho Chi Minh City.

HOURS OF WORK
Full-time

TENURE
This is a 1 year contracted position with possibility of extension to 36 months

REPORTING TO
Head of Clinical Trials Unit

ESSENTIAL CRITERIA

• Degree in Pharmacy, Science, Public Health or a related field
• Strong diplomatic skills
• Proven oral and written presentation skills
• Excellent communication and interpersonal skills
• High level of organizational and record keeping skills
• Project management training and experience
• Excellent Vietnamese and English language skills

DESIRED CRITERIA

• Experience conducting or managing clinical trials
• In depth understanding of ICH-GCP
• Industry experience
• Work experience of a Health Research Institution

BENEFITS

• Contracted salary: Negotiate (depending on actual experience and education).
• Optional insurance : In-patient and out-patient medical coverage; Personal accident insurance coverage
• Two months salary for annual bonus and clothes
• Annual leave 18 days/year for the first year, a maximum of 30 days
• Other responsibilities and benefits are based on Viet Nam Labor Law.

HOW TO APPLY

Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant degrees, certificates, either by email or by post to the following address:
Oxford University Clinical Research Unit
Laboratory of Clinical Science
Hospital for Tropical Diseases
764 Vo Van Kiet, Ward 1, District 5, HCMC

DEADLINE FOR SUBMISSION
15th October 2019

* We thanks all applicants for their interests but only short-listed candidates will be contacted for interview.

- Contracted salary: Negotiate

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