Senior Clinical Trial Officer

2 weeks ago


Ho Chi Minh City, Ho Chi Minh, Vietnam Woolcock Full time

Job description - Senior Clinical Trial Officer

Job code:

Job category:
Clinical Trials

Job level:
Senior Officer

Type of work:
Full-time

Duration: 12 months with the possibility of subsequent extension

Location:
Ho Chi Minh City, may require domestic travel to research sites

Regional office:

HCMC

Direct report:
Clinical Trial Coordinator/Regional Clinical Trial Lead

Dotted-line reporting:

Tentative start date:
May 2023

Organisation:
Woolcock Institute of Medical Research


The Woolcock Institute of Medical Research is affiliated with the University of Sydney in Australia and is recognized as one of the leading research institutions for respiratory diseases and sleep disorders.

Operating in Vietnam since 2009, we have undertaken large operational, epidemiological, and clinical research projects and run training in epidemiological and operational research methods for Vietnamese doctors and public health workers.

The Woolcock Institute has three research centres and offices in Ha Noi, Ho Chi Minh City, Ca Mau, and Can Tho.

Currently, we directly employ about 80 full-time staff and coordinate multiple study projects within lung health management and treatment across eleven provinces.

We also expand research activity to other fields including antimicrobial resistance.

For more information about us, please visit:

Duties and Responsibilities:

  • To work with research and clinical team to implement study components in clinical trial including but not limited to contributing to contract negotiation, finalizing SOP, CRFs, coordinating study activities at all responsible sites from startup to closeout, and working with other Clinical Trial Officers in recruitment and case management.
  • Working with the international Coordinating Centre to address issues relating to data quality, protocol implementation, reporting and monitoring.
  • Assist in performing site qualification, site initiation, interim monitoring, site management and closeout visits (performed onsite or remotely) to ensure regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding sitespecific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and study SOPs/processes.
  • Perform investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
  • Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents activities via confirmation letters, followup letters, site visit reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site
  • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Attends clinical training sessions according to the project specific requirements.
  • Provide training to more junior level study staff. May perform training and sign off visits for junior study staff, as assigned.
  • May be mentored and assigned clinical operations lead tasks under supervision of Regional Clinical Trial Lead/Clinical Trial Coordinator.
  • Per the Clinical Monitoring/Site Management Plan (CMP/SMP), assist Internal Monitor in:
  • Assessing site processes;
  • Conducting Source Document Review of appropriate site source documents and medical records;
  • Verifying required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records;
  • Utilizing available hardware and software to support the effective conduct of the clinical study data review and capture;
  • Verifying site compliance with electronic data capture requirements.
  • Translate study documents (Vietnamese
  • English
  • Vietnamese)
  • Support in organizing logistics of study materials including drugs, files, test kits, patient samples, data and other materials.
  • Purchase study materials when required.
  • Other tasks as required.

Key attributes:

  • 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.
  • Scientific and/or clinical knowledge needed to monitor the trial adequately.
  • Understanding of ICH-GCP guidelines, local and international regulations on clinical research.
Selfstarter, detail-oriented, good time m
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