Clinical Research Cordinator (Điều Phối Viên Nghiên Cứu Lâm Sàng)

* Background
Big Leap Clinical Research Support Joint Stock Company (or “Big Leap Research”) is one of the first local Contracted Research Organizations (CROs) in Vietnam with built-in capacity to provide clinical research supporting and site management services.
With our expertise and extensive network in Vietnam Clinical Trials Industry, Big Leap Research has provided clinical research supporting – consulting services to a multitude of global and local pharmaceutical companies, biotechnology companies, medical device companies and other CROs. As of January 2019, we have managed over 40 clinical research studies in 12 different therapeutic areas across 36 major hospitals throughout Vietnam. Our project portfolio mainly consists of multi-national, multi-institutional studies in Oncology, Pulmonary, Cardiovascular and Infectious diseases.
At Big Leap Research, we are committed to provide you the best Quality of Service every step of the way: feasibility assessment, regulatory submission, site negotiation, clinical research site supporting, monitoring and project management. As your partner, we will support you throughout the entire process and help you attain the desired outcomes for your clinical research trials in Vietnam.

* Job summary:
A highly motivated Coordinator is required to work with in our clinical trials unit (CTU) to work with BIG LEAP’s Principle Investigators (PIs) and local partners to coordinate and manage the implementation of BIG LEAP research projects across Vietnam, including both clinical and community-based studies; to ensure efficient and high quality research operations in line with international standards; to contribute to the continued growth and development of BIG LEAP’s research portfolio in Vietnam

* Key tasks and responsibilities: CRC assists the sponsors/PIs in doing the following tasks:
• Support screening and selecting patients;
• Support the establishment of "Patient file" (patient records) (if any);
• Support PIs to import data into CRF/eCRF;
• Supports storage, management of source data, as well as all records and related document;
• Support in drafting SOPs;
• Support the implementation of research in accordance with the protocol, SOP and GCP (monitoring and guiding procedures to ensure the proper implementation);
• Check and prepare necessary testing equipment for the study;
• Support for checking and updating information into required records (such as Update investigator file, patient binder ...);
• Support the monitoring of patients (schedule and remind schedule of visits ...);
• Support AE / SAE report;
• Support login, activate, update to the research system (web-based system) if any;
• Preparing documents, necessary files to meet the supervision and inspection

* Selection criteria Essential Criteria:
• Work location: Ho Chi Minh and Ha Noi. Prioritize Ha Noi
• Medical Doctor, Public health, Pharmacy, Nurse
• Good understanding of general ethical considerations applicable to research and good clinical practice (GCP) guidelines and other relevant regulations in conducting studies, including clinical trials
• High Intermediate level of English comprehension, including the ability to do translations from English to Vietnamese and vice versa
• Excellent interpersonal communication/diplomatic skills with people of different backgrounds and social positions
• Excellent Vietnamese language skills: listening, speaking, reading, writing.

* Benefits
• Contracted salary: Negotiate (depending on actual experience and education)
• Bao Viet Personal insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage
• 13th month salary (annual bonus)
• Holidays Bonus
• Annual leave 12 days/year
• Vietnam Social & Health insurance, Sick leave, Personal leave, Maternity leave and National holidays will be based on Vietnam Labor Law

* How to apply
* Interested candidates are invited to send curriculum vitae, application and copies of relevant certificates, by post to Big Leap Clinical Research Support Joint Stock Company
HCM Head Office: 3F, 132-134 Dien Bien Phu, Da Kao Ward, District 1, Ho Chi Minh City
Hanoi Office: 8F, 30 Mai Hac De, Bui Thi Xuan District, Hanoi City
Or apply directly to Vietnamworks.

* Only short-listed candidates will be notified. Please no telephone contact after submitting the application

- 13th month salary (annual bonus)
- Vietnam Social & Health insurance, Sick leave, Personal leave, Maternity leave and National holidays
- Holidays Bonus & Annual leave 12 days/year

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