Senior Trial Officer

Job description – Senior Trial Officer

Organisation: Woolcock Institute of Medical Research in Vietnam

The Woolcock Institute is leading international lung health research organisation, affiliated with the University of Sydney in Australia (https://sydney.edu.au/ [1]). The Woolcock Institute has operated researches in Vietnam since 2009 and undertaken large operational, epidemiological and clinical research projects in several provinces, including Ha Noi and Ho Chi Minh City. The Woolcock also runs training in epidemiological and operational research methods for Vietnamese doctors and public health workers. Currently the Woolcock directly employs about 50 full-time staff and has expanded the research activity to other fields, including antimicrobial resistance, climate change, agriculture, environmental health, etc.

Overview: Since 2015, the Woolcock has implemented the VQUIN Study which is a large-scale study - a community-based cluster randomised double-blind placebo controlled trial to test the effectiveness of treatment of LTBI for contacts of patients with MDR-TB. The study is conducted in 10 provinces in Vietnam from 2015-2020. VQUIN is recruiting dynamic and an active Senior Trial Officer to join our team in Hanoi or HCMC.

Location: Ho Chi Minh City/Ha Noi
Duration: Full time - 12 months appointment, with consideration for subsequent extension. This position will begin as soon as possible in 2021.

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 Trial Officers in recruitment and case management.
• To work 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 close-out visits (performed on-site 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 site-specific 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. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
• 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, follow-up letters, site visit reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan, and requirements of study sponsor/funder/investigator(s). Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• 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 Area Leader/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 medica records
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
  • Verifying required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
  • Applying query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
  • 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.

Direct report:
Trial Coordinator/Area Leader

Senior report:
Country Director, Woolcock Institute of Medical Research in Vietnam

Key attributes/ Selection criteria:

• 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.
• Self-starter, detail-oriented, good time management, problem solver, flexible and adaptable, self-confident
• Willing to travel within Viet Nam

Application Procedure

For interested applicants, please send a cover letter together with a CV (with the name and contact details of at least three senior referees) in English or Vietnamese and scanned copies of your related degrees, no later than 28th February 2021 by submitting the application form in the link as follows:
https://airtable.com/shrEHhrmyayGTWOjs [2]

We regret that only short-listed candidates will be contacted for interviews. Review of applications will start as soon as possible and continue until 28/02/2021, or until the post is filled, whichever is earlier.