Clinical Research Monitor

2 weeks ago

Hanoi, Vietnam oxford university clinical research unit Full time

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
OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.
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.
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.

**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 Verify the reporting of safety events and protocol non
- compliance
- Ø Verify investigational product records and inventory
- Ø Verify that each participant or their representative has given informed consent to participate in the study
- Ø Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures
- Ø Write monitoring reports to summarize findings at a site
- Ø Ensure all study staff at the site has a clear and accurate understanding of how the study is to be conducted
- Ø Confirm accuracy and completeness of source documents and CRFs
- Ø Meet with study staff to explain findings and support staff to correct non
- compliance
- Ø Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
- Ø Confirm that the site has adequate qualifications and resources to start the study
- Ø Verify participant eligibility- Other tasks as required
- Attend career training to improve skills and update relevant knowledge
- Support to review study SOPs at the set
- up phase
- Maintain an up
- to
- date understanding of clinical research conducted by OUCRU- VN
- Help to maintain the clinical trials unit quality assurance systems.
- Translate study documents (Vietnamese
- English - Vietnamese)

Selection criteria
- Essential:
- Excellent Vietnamese and English language skills.
- Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.
- Excellent diplomatic communication and interpersonal skills.
- Proven oral and written presentation skills.
- High level of organizational and record keeping skills.
- Understanding of ICH- GCP guidelines, local and international regulations on clinical research.
- Experience in conduct, coordinating, monitoring or quality assuring of 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:
- Scientific and/or clinical knowledge needed to monitor the clinical resear

  • Clinical Research Monitor

    6 days ago

    Hanoi, Hanoi, Vietnam oxford university clinical research unit Full time

    GroupClinical Trials Unit (CTU)LocationThis post is based in Ha Noi, with some travel required.Hours of workFull time: Monday - Friday, 37.5 hours per week, extra hours may be requiredTenureInitially for 01 year, including a 02- month probation period, with possibility of extension based on annual performance appraisalReporting toCTU ManagerVacancy...

  • Clinical Research Monitor

    6 days ago

    Hanoi, Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time

    Mô tả công việc:(Mức lương: Thỏa thuận)Mô tả Công việcGroupClinical Trials Unit (CTU)LocationThis post is based in Ha Noi, with some travel required.Hours of workFull time: Monday - Friday, 37.5 hours per week, extra hours may be requiredTenureInitially for 01 year, including a 02-month probation period, with possibility of extension...

  • Clinical Research Monitor

    2 weeks ago

    Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time

    **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...

  • Clinical Research Coordinator

    3 weeks ago

    Hanoi, Vietnam UNC Full time

    **JOB ANNOUNCEMENT - CLINICAL RESEARCH COORDINATOR** **Position**: Clinical Research Coordinator Full-time, based in Hanoi **Report to**: Clinical Research Manager & Investigator of Record (IoR) **Position Summary**: The Clinical Research Coordinator (CRC) will oversee and perform daily clinical trial activities to ensure the studies are conducted in...

  • Clinical Research Coordinator

    3 weeks ago

    Hanoi, Vietnam UNC Full time

    **JOB ANNOUNCEMENT - CLINICAL RESEARCH COORDINATOR** **Position**: Clinical Research Coordinator Full-time, based in Hanoi **Report to**: Clinical Research Manager & Investigator of Record (IoR) **Position Summary**: The Clinical Research Coordinator (CRC) will oversee and perform daily clinical trial activities to ensure the studies are conducted in...

  • Clinical Research Associate

    2 months ago

    Hanoi, Vietnam MSD Full time

    **Job Description**: **THE OPPORTUNITY** - Permanent Headcount with International Pharmaceutical company - Multiple therapeutic area study to explore your clinical experience - Best team and career development with company **WHAT YOU WILL DO** - Develops strong site relationships and ensures continuity of site relationships through all phases of the...

  • Clinical Research Coordinator

    6 days ago

    Hanoi, Hanoi, Vietnam UNC Full time

    JOB ANNOUNCEMENT - CLINICAL RESEARCH COORDINATORPosition: Clinical Research CoordinatorFull-time, based in HanoiReport to: Clinical Research Manager & Investigator of Record (IoR)Position Summary:The Clinical Research Coordinator (CRC) will oversee and perform daily clinical trial activities to ensure the studies are conducted in compliance with protocols,...

  • Clinical Research Associate

    6 days ago

    Hanoi, Hanoi, Vietnam MSD Full time

    Job Description:THE OPPORTUNITY Permanent Headcount with International Pharmaceutical company Multiple therapeutic area study to explore your clinical experience Best team and career development with companyWHAT YOU WILL DO Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study...

  • Clinical Research Associate

    3 weeks ago

    Hanoi, Vietnam MSD Full time

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, Our company policies and procedures, quality standards and adverse event reporting requirements internally and...

  • Post-doctoral Health Economist

    2 weeks ago

    Hanoi, Vietnam oxford university clinical research unit Full time

    Group 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

    6 days ago

    Hanoi, Hanoi, Vietnam oxford university clinical research unit Full time

    GroupResearchLocationThis post is based in Ha Noi, with some travel required.Hours of work5 hours per week, extra hours may be required.TenureInitially for 01 year, including a 02 month probation period, with possibility of extension.Reporting toDirector of OUCRU Ha NoiVacancy referenceJDHAN_0224_001BackgroundThe Oxford University Clinical Research Unit...

  • Senior Clinical Research Associate 1

    2 months ago

    Hanoi, Vietnam Novasyte Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Senior Clinical Research Associate 1

    1 day ago

    Hanoi, Vietnam Novasyte Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Project Manager

    6 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 Clinical Trials Unit Location Base in OUCRU (Hanoi or HCMC) 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. Reporting...

  • Post-doctoral Health Economist

    2 weeks 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...

  • Project Manager

    6 days ago

    Hanoi, Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time

    Mô tả công việc:(Mức lương: Thỏa thuận)Mô tả Công việcGroupClinical Trials UnitLocationBase in OUCRU (Hanoi or HCMC)Hours of workFull time: Monday - Friday, 37.5 hours per week, extra hours may be required.TenureInitially for 01 year, including a 02 month probation period, with possibility of extension.Reporting toAWARE1 PIBackgroundThe...

  • Clinical Research Associate Smm

    6 days ago

    Hanoi, Hanoi, Vietnam AstraZeneca Full time

    Clinical Research Associate SMM - ONCO - HNAbout AstraZeneca and AstraZeneca VietnamAstraZeneca is a global, science-led biopharmaceutical company with a British-Swedish heritage that focuses on the discovery, development, and commercialization of prescription medicines. At AstraZeneca, science and patients are at the heart of everything we do. Based in...

  • Senior Clinical Research Associate 1

    2 months ago

    Hanoi, Vietnam IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Senior Clinical Research Associate 1

    1 day ago

    Hanoi, Vietnam IQVIA Full time

    Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

  • Post-doctoral Health Economist

    6 days ago

    Hanoi, Hanoi, Vietnam Oxford University Clinical Research Unit - Vietnam Full time

    Mô tả công việc:(Mức lương: Thỏa thuận)Mô tả Công việcGroupResearchLocationThis post is based in Ha Noi, with some travel required.Hours of work37.5 hours per week, extra hours may be required.TenureInitially for 01 year, including a 02 month probation period, with possibility of extension.Reporting toDirector of OUCRU Ha NoiVacancy...