Position: Senior Clinical Research Associate (Monitor)
Department: Clinical Trials Unit (CTU)
Location: This post is based in Ho Chi Minh City, with travel required.
Hours of work: 37.5 hours per week, extra hours may be required.
Tenure: Initially for six months, including a 1 month probation period, with possibility of extension.
Reporting to: Head of CTU
Vacancy reference: JD-0316-011
Background
Originally established in 1991, OUCRU has developed strong links with many hospitals throughout Viet Nam, Asia, Africa and South America. The unit’s strategic aim is to have a positive and significant impact on global health and, in particular, the prevention, diagnosis and treatment of infectious diseases. This is being achieved via an integrated long-term research programme, contributions to training, the scientific literature, national and international meetings and membership of national and international committees. OUCRU is currently conducting a large number of research studies including clinical trials of drugs and vaccines. An experienced and highly motivated senior quality assurance associate is required to ensure quality and regulatory compliance of research as well as contribute to clinical research capacity development in Asia.
The post-holder will be based within the OUCRU-VN Clinical Trials Unit and be responsible for monitoring trials conducted or managed by OUCRU in Asia, Africa and South America.
Job summary
The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified quality assurance officer to ensure efficient and high quality research operations in line with international standards. The Senior Quality Assurance Associate will perform clinical trials monitoring in compliance with the guidelines of Good Clinical Practice from the International Conference on Harmonization, the Medical Research Council-UK, the Viet Nam Ministry of Health or other local regulatory authorities in addition to developing and maintaining quality assurance systems in study processes including laboratory, data management and drug management processes. The post holder will contribute to the continued growth and development of the CTU team and collaborating research units internationally.
Key responsibilities and tasks
The post holder will report to the OUCRU-VN Head of CTU and will be responsible for (but is not limited to) the following tasks:
- Perform a risk analysis for new studies. Use the results of this analysis to write a monitoring plan.
- Implement the monitoring plan by arranging visits with the study site based on study progress.
- Work with study coordinator to conduct monitoring visits to verify compliance of study conduct with the required guidelines and study plans including (but not limit to):
- Confirm that the site has adequate qualifications and resources to start the study
- Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted
- Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
- Verify that each participant or their representative has given informed consent to participate in the study
- Verify participant eligibility
- Confirm accuracy and completeness of source documents and CRFs
- Verify the reporting of safety events and protocol non-compliance
- Verify investigational product records and inventory
- Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
- Meet with study staff to explain findings and support staff to correct non-compliance
- Write monitoring reports to summarize findings at a site
- Build a good relationship with study sites and act as a liaison between OUCRU-VN and sites.
- Help develop quality assurance systems for study processes including laboratory, data management and drug management processes.
- Implement and maintain these quality assurance systems.
- Contribute to the development of CTU systems, procedures and documentation, especially those relating to monitoring and quality management.
- Consult with collaborating research units in Viet Nam and internationally. Create and support the execution of development plans which increase clinical research capacity and quality.
- Maintain an up-to-date understanding of trials conducted by OUCRU-VN.
- Attend career training to improve skills and update relevant knowledge.
- Translate study documents (Vietnamese - English – Vietnamese)
- Other tasks as required.
Selection criteria
Essential:
- Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.
- Experience in conduct, coordinating, monitoring or quality assuring of clinical research
- Proven oral and written presentation skills.
- Excellent diplomatic communication and interpersonal skills.
- High level of organizational and record keeping skills.
- Excellent Vietnamese and English language skills.
- Scientific and/or clinical knowledge needed to monitor the trial adequately
- Understanding of ICH-GCP guidelines, local and international regulations on clinical research.
- Self-starter, detail-oriented, good time management, problem solver, flexible and adaptable, self-confident
- Willing to travel within Viet Nam and abroad.
Desired:
- Experience working as a clinical research monitor
How to apply
Interested qualified candidates are invited to send their detailed resume and cover letter in English, including copies of relevant 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
Tel: 39237954
Email: [email protected] [1]
Only short-listed candidates will be contacted for interview.
Contact person: Ms. Nguyen Thi Hong Phuc
Deadline for submission: 18th April 2016