Clinical Specialist ★ 4.2

Mô tả Công việc

JOB SUMMARY

The recent, impressive growth in clinical trials capacity and opportunity needs to be matched with trained and qualified clinical research staff to ensure efficient and high-quality research operations in line with international standards.

The candidate will join a dynamic group running clinical research. This position will be based at the Clinical Trial Unit (CTU) at OUCRU HCMC, under the supervision of the Clinical Research Manager.

The successful candidate will be the main Research Coordinator for the Tuberculosis studies at the Hospital for Tropical Diseases, HCMC, Pham Ngoc Thach (PNT) hospital, Nhi Dong hospitals and also support other studies as needed.

KEY TASKS AND RESPONSIBILITIES

Key responsibilities include but are not limited to

- Responsible for conducting all Science and Ethics committee submissions:

o Conducting protocol and study documents pre-reviews:

§ Work with the trial staff for each new study to ensure the protocol and procedures comply with the applicable local and international regulatory standards.

§ Review clinical trial protocols in order to identify inconsistencies, errors and omissions.

o Conducting the submission and tracking of regulatory and ethical applications for clinical research to relevant local and international bodies.

o Being key contact to communicate IRB decisions and rationale to investigators.

o Maintain regulatory filing of essential documents for each study in accordance with the principles of Good Clinical Practice.

- Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international.

o Provide consultation/ education to investigators and research staff about the updated knowledge of human subject protection regulations and institutional policies.

o Provide guidance to staff regarding the policies of the Clinical Trials Unit and implementation of those policies.

- Support the SAE reporting procedure, help PIs and coordinators to liaising with local ECs and MoH to send the SAE reports as required by the local ECs and MoH guideline

- Contribute in the development of study and site procedures for good research governance.

- Help study staff to develop appropriate ways to document all processes in a research study

- Act as the primary contact for local and national regulatory bodies regarding clinical trials.

- Perform general administrative duties as needed.

- Verify study document translation (English – Vietnamese)

- Contribute to the development of CTU systems, procedures and documentation, especially those relating to governance processes.

- Attend career training to improve skills and update relevant knowledge

- Assist actively with the organization and delivery of training in the guidelines of Good Clinical Practice

- Other tasks as required.

DEPARTMENT

Clinical Trials Unit (CTU)

LOCATION

This post is based in Ho Chi Minh City, Viet Nam. There may be occasional requirement to travel within Viet Nam.

HOURS OF WORK

Full-time Monday – Friday, 37.5 hours per week.

TENURE

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

REPORTING TO

Ethics Team Leader