Internal Study Monitor – MRD Prevention Study

Job description: Internal Study Monitor – MRD Prevention Study

Organisation: The Woolcock Institute is leading international lung health research organisation, affiliated with the University of Sydney in Australia (https://sydney.edu.au/). The Woolcock Institute has operated in Vietnam since 2009, we undertake large and important operational and epidemiological and clinical research projects in collaboration with the National Tuberculosis Program in 11 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 45 full-time staff in Hanoi, Ho Chi Minh City and Ca Mau.

Location: Ha Noi. The position requires monitoring trips to Ha Noi, Nam Dinh, Thanh Hoa, Quang Nam, Da Nang.

Duration: 12 months appointment, with consideration for subsequent extension.

Direct report: VQUIN Trial Manager

Key staff working in the project:

• Trial Manager, Area Leader, Trial Officers
• Local health workers
• Local financial controller
• Technical managers (such as Laboratory staff)

Duties and Responsibilities:

• Work with Trial coordinator and Area Leaders to conduct monitoring visits to verify compliance of study conduct with the required guidelines and study plans including (but not limit to):
  
  • Review study documents to ensure compliance with regulatory requirements and quality standards. Ensure maintenance of essential documents
  • Confirm that the site has adequate qualifications and resources for the study conduct
  • Verify that each participant or their representative has given informed consent to participate in the study
  • Verify participant eligibility
  • Confirm accuracy and completeness of source documents and CRFs (electronic and paper)
  • Verify the reporting of safety events and protocol non-compliance
  • Verify investigational product records and inventory
  • Meet with study staff to explain findings and support staff to correct errors, non-compliance with research protocol
  • Write monitoring reports to summarize findings at a site
  • Help develop quality assurance systems for study processes including laboratory, data management and drug management processes
  • Implement and maintain these quality assurance systems

• Train site staff on Good Clinical Practice guidelines, the study protocol and study procedures

• Contribute to the development of VQUIN systems, procedures and documentation, especially thoserelating to monitoring and quality management

• Translate study documents (Vietnamese - English – Vietnamese)

• Build a good relationship with study sites and act as a liaison between WIMR and sites

• Other tasks as required

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

Interested applicants should send a cover letter together with a CV in English no later than 30th September 2018 by submitting the application form in the link as follows: https://airtable.com/shrEHhrmyayGTWOjs.

We regret that only short-listed candidates will be contacted for interviews.