Clinical Research Monitor
3 days ago
**Mô tả công việc**:
(Mức lương: Thỏa thuận)
Mô tả Công việc
Group
Clinical Trials Unit (CTU)
Location
This post is based in Ha Noi, with some travel required.
Hours of work
Full time: Monday - Friday, 37.5 hours per week, extra hours may be required
Tenure
Initially for 01 year, including a 02-month probation period, with possibility of extension based on annual performance appraisal
Reporting to
CTU Manager
Vacancy reference
JDHAN_0224_002
Background
The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU Nepal has partnerships with the Patan Academy of Health Sciences and Patan Hospital, and OUCRU Indonesia exists in partnership with the University of Indonesia. As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.
OUCRU's vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care.
OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
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 Monitor 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.
**Chức vụ**: Nhân viên/Chuyên viên
**Hình thức làm việc**: Toàn thời gian
**Quyền lợi được hưởng**:
Laptop
Chế độ bảo hiểm
Du Lịch
Chế độ thưởng
Chăm sóc sức khỏe
Đào tạo
Tăng lương
Công tác phí
Nghỉ phép năm
**Yêu cầu bằng cấp (tối thiểu)**: Đại Học
**Yêu cầu công việc**:
Yêu Cầu Công Việc
Key responsibilities and tasks
The post holder will report to the OUCRU-HN CTU Manager and will be responsible for (but is not limited to) the following tasks:
- 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):
Ø Confirm that the site has adequate qualifications and resources to start the study
Ø Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted
Ø Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
Ø Verify that each participant or their representative has given informed consent to participate in the study
Ø Verify participant eligibility
Ø Confirm accuracy and completeness of source documents and CRFs
Ø Verify the reporting of safety events and protocol non-compliance
Ø Verify investigational product records and inventory
Ø Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
Ø Meet with study staff to explain findings and support staff to correct non-compliance
Ø Write monitoring reports to summarize findings at a site
- Help to maintain the clinical trials unit quality assurance systems.
- Support to review study SOPs at the set-up phase
- Maintain an up-to-date understanding of clinical research 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 or
-
Clinical Research Monitor
3 days ago
Hanoi, Vietnam oxford university clinical research unit Full timeGroup Clinical Trials Unit (CTU) Location This post is based in Ha Noi, with some travel required. Hours of work Full time: Monday - Friday, 37.5 hours per week, extra hours may be required Tenure Initially for 01 year, including a 02- month probation period, with possibility of extension based on annual performance appraisal Reporting to CTU Manager Vacancy...
-
Post-doctoral Health Economist
3 days ago
Hanoi, Vietnam oxford university clinical research unit Full timeGroup Research Location This post is based in Ha Noi, with some travel required. Hours of work 5 hours per week, extra hours may be required. Tenure Initially for 01 year, including a 02 month probation period, with possibility of extension. Reporting to Director of OUCRU Ha Noi Vacancy reference JDHAN_0224_001 Background The Oxford University Clinical...
-
Post-doctoral Health Economist
3 days ago
Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) Mô tả Công việc Group Research Location This post is based in Ha Noi, with some travel required. Hours of work 37.5 hours per week, extra hours may be required. Tenure Initially for 01 year, including a 02 month probation period, with possibility of extension. Reporting to Director...
-
Clinical Trainer
3 weeks ago
Hanoi, Vietnam Novotech Asia Full time**Brief Position Description**: Clinical Trainer is primarily responsible for assisting Clinical L&D Manager in training curriculum development including material development (user manuals, reference guides, iHelp, training videos, FAQs, Workflows etc), maintenance and formal delivery to internal/external users for all applicable clinical trainings. The...
-
Academic Assistant for Clinical Education
1 week ago
Hanoi, Vietnam Công ty TNHH Giáo dục và Đào tạo VinAcademy Full time**Mô tả công việc**: (Mức lương: Thỏa thuận) THE OPPORTUNITY - With oversight and direction from the Vice Dean for Clinical Education, the Academic Assistant for Clinical Education is responsible for the operational and financial management of Clinical Education activities. The position requires a comprehensive and detailed understanding of...
-
Clinical Operations Manager
4 days ago
Hanoi, Vietnam MSD Full time**Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Our Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...
-
Consultant RHeumatologist
1 day ago
Hanoi, Vietnam Align Recruitment Full time**Posting** ** AR-199 **Title** **Consultant Rheumatologist & Clinical Medical Director - Hanoi, Vietnam - AR-199**: **City** ** Hanoi **Country** ** Vietnam **Profession** ** Rheumatology **Job Type** ** Permanent Full-Time **Relocation** ** Yes **Salary** ** US$8,000 to $9,000 per month net after taxes paid by the employer **Start Date** **...
-
Director of Clinical Genetics Center
2 weeks ago
Hanoi, Vietnam Employment Vietnam Full timePioneering international-standard-healthcare in Vietnam, our client boasts two Joint Commission International (JCI) -accredited hospitals. Dedicated to excellence, they prioritize patient well-being, while advancing academic medicine and technology for revolutionary treatments. They are looking for **_DIRECTOR OF CLINICAL GENETICS CENTER_** who will develop...
-
Clinical Operations Manager
2 days ago
Hanoi, Vietnam MSD Full time**Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is...
-
Clinical Trial Coordinator
2 weeks ago
Hanoi, Vietnam MSD Full time**Job Description**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...
-
Clinical Marketing Executive
1 week ago
Hanoi, Vietnam Siemens Healthineers Full timeDo you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally...
-
Monitoring, Evaluation, Accountability
4 days ago
Hanoi, Vietnam Save the Children Full time**The Opportunity - **Monitoring, Evaluation, Accountability & Learning (MEAL) Coordinator** The MEAL Coordinator is responsible to build up Research, Evaluation, Accountability, Learning and Monitoring (REALM) plans, monitor and measure program’s outputs, outcomes and impacts according to the agreed indicators, to facilitate capturing lessons learned in...
-
Hanoi, Vietnam Winrock International Full timeWinrock International works with people around the world to increase economic opportunity, sustain natural resources, and protect the environment. Winrock is seeking a Monitoring, Evaluation, Results, and Learning (MERL) Manager to be part of a dynamic team in implementing an anticipated $25-49.99 million dollar USAID-funded project to address climate...
-
UX Researcher
1 week ago
Hanoi, Vietnam Seal Commerce ASIA Full time**Mô tả công việc**: (Mức lương: Đến 45 triệu VNĐ) Why we’re looking for you Our mission is to understand the people who will use our products so that we can make informed decisions across the organization through evidence-based insights. To do that, we are hiring a User Research with a range of expertise from mixed-methods generalists to...
-
DevOps Engineer
7 days ago
Hanoi, Vietnam VinAI Research Full time**DevOps Engineer (IT Infrastructure Team)**: As a DevOps Engineer to Join IT Team who will be in charge of infrastructure management with experience for both cloud and on-premises **What you’ll do**: - Setup environments for applied and research teams. - Handle reliability and scalability of AI system and data platforms. - Manage and allocate GPU...
-
Hanoi, Vietnam Save the Children Full time**The Opportunity - **Monitoring Evaluation, Accountability and Learning (MEAL) Officer** The MEAL Officer is responsible to facilitate MEAL related works at projects and program level. He or she will collaborate with project/ program team to monitor and measure that projects’ outputs, outcomes and impacts are achieved according to the agreed indicators,...
-
Application Specialist
1 week ago
Hanoi, Vietnam BD Full time**Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...
-
Application Specialist
1 week ago
Hanoi, Vietnam BD Full timeJob Description Summary **Job Description**: We are the makers of possible BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...
-
Research Manager
7 days ago
Hanoi, Vietnam NavigosSearch Full time**What We Can Offer**: Navigos Search's client, Japanese consulting company (have close relationships with government dept., trade promotion organizations of Japan) to recruit a Research manager with details as below: 1. Main duties - Management responsibility - Hold meetings with clients and prepare proposals - All the functions of a researcher - from...
-
Research & Organizational Learning Intern
1 week ago
Hanoi, Vietnam Social Impact Full time**Research & Organizational Learning Intern** **Under the Learns’ Young Professional Program** USAID Learns Hanoi, Vietnam **About Social Impact** Social Impact (SI) is a global development management consulting firm. We provide monitoring, evaluation, strategic planning, and capacity-building services to advance development effectiveness. We work...