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

• Track study progress and identify problems. Report to supervisor and PIs as required.
• Coordinate logistical, training and reporting tasks in the studies.
• Contribute to development of Research SOPs.
• Organise, conduct and follow-up site initiation visits, routine monitoring and close out visits as per relevant study plan.
• Motivate and train investigators and site staff to ensure obligations in regards to study timelines.
• Verify the quality, accuracy, completion and timeliness of data. Completely and efficiently resolve data and audit queries and issues
• Adhere to the study protocol and study procedures manual. Comply with the mandatory SOPs agreed for the study
• Complete reports accurately and within the specified timelines

Key tasks include but are not limited to:

• Understand study protocols and ensure sites comply with protocol and GCP requirements.
• Manage logistical aspects for study set up and implementation (eg ethical approvals, import permits, purchasing, IT systems).
• Follow up the contracts with study sites according to the project agreements.
• Liaise with the study teams and sites face-to-face, or by email/social media, and with collaborators.
• Liaise with research monitoring/audits and support the study team to answer reports.
• Take a part in developing CRFs of studies.
• Ensure data is entered accurately and completely by frequent data tracking.
• Oversee data cleaning in preparation for analysis. Verify that data entered on the CRFs is complete and consistent with patient clinical notes, known as source data/document verification.
• Other support 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

Clinical Research Manager