Clinical Research Monitor (JD-0124-003)

Oxford University Clinical Research Unit (OUCRU Vietnam)

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Ngày cập nhật: 21-04-2024

Địa điểm: Hồ Chí Minh

Ngành nghề: Phi chính phủ/ Phi lợi nhuận Y tế/ Chăm sóc sức khỏe Dược Phẩm/ Hóa học/ Sinh học

Vị trí: Nhân viên

Mức lương: 1,092 - 1,335 USD

Trình độ: Đại học

Kinh nghiệm: 2 - 10 Năm

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Mô tả công việc

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.

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KEY TASKS & RESPONSIBILITIES

The post holder will report to the OUCRU-VN Head of CTU/ Vice Head of CTU/ Monitor Team Leader 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

· 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.

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GROUP

Clinical Trials Unit (CTU)

LOCATION

This post is based in Ho Chi Minh City, with some travel required.

HOURS OF WORK

Full time. 37.5 hours per week, extra hours may be required

TENURE

Initially for 1 year, including a 2-month probation period, with the possibility of extension.

REPORTING TO

Head of CTU/ Vice Head of CTU/ Monitor Team Leader

Yêu cầu công việc

ESSENTIALCRITERIA

· 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.

· 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.

DESIREDCRITERIA

· Experience working as a clinical research monitor

· Scientific and/or clinical knowledge needed to monitor the trial adequately

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BENEFITS

- Contracted salary:

o Grade: RS3/IC3

o Salary ranges: $ 1,092 - $ 1,335 gross per month

- 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.

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HOW TO APPLY

Interested candidates are invited to send curriculum vitae, application, writing samples and copies of relevant certificates, by email to

Oxford University Clinical Research Unit

Laboratory of Clinical Science

Hospital for Tropical Diseases

764 Vo Van Kiet, Ward 1, District 5, HCMC

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DEADLINE FOR SUBMISSION

28 January 2024

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* We thank all candidates for their interest, but only short-listed applicants will be notified for interview.

Quyền lợi công việc

  • Chế độ bảo hiểm
  • Du Lịch
  • Chế độ thưởng
  • Chăm sóc sức khỏe
  • Đào tạo
  • Tăng lương
  • Công tác phí
  • Nghỉ phép năm
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Hạn nộp: 21-05-2024

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