Clinical Research Coordinator

JOB DESCRIPTION

Post: Clinical Research Coordinator

 



ORGANIZATION & RESEARCH BACKGROUND



Oxford University has two Clinical Research Units in Viet Nam: one in Ho Chi Minh City and one in Hanoi (www.oucru.org)

Oxford University Clinical Research Unit Vietnam (OUCRU-VN) has been working in Viet Nam for more than 25 years on infectious diseases studies and has a well-established research program, facility and partnership with the National Hospital for Tropical Diseases and a network of hospitals across Viet Nam and Asia to conduct a wide range of clinical studies including clinical trials.

The Unit in Hanoi focuses on influenza in the community and antibacterial resistance at all levels, from laboratory diagnostics, to clinical trials, national guideline development and policy influencing.  



OVERVIEW OF THE ROLE



A highly motivated Coordinator is required to manage the implementation of research projects; to support and develop the current research activities; to ensure efficient and high quality research operations in line with international standards; to contribute to the continued growth and development of the research team and to be responsible for coordinating a number of trials and other studies across Viet Nam.



LOCATION



OUCRU-VN office at the National Hospital for Tropical Diseases, 78 Giai Phong, Dong Da, Hanoi. Travel to hospitals or units around Hanoi will be required regularly.  Travel within Viet Nam or internationally will be required. The post holder will be expected to work in clinical areas (wards and outpatient departments) as well as in community settings depending on the projects they are assigned to.



LENGTH OF CONTRACT



One year contract and extension based on annual performance appraisal and Research approval



PROBATION PERIOD



Two months.



REPORT TO



Behzad Nadjm, Hanoi CTU head



HOURS OF WORK



37,5 hours/week – Monday to Friday



BENEFIT



  • Contracted salary:  Negotiate (depending on actual experience and education)

  • Optional insurance: In-patient and out-patient medical coverage; Personal accident insurance coverage

  • 13th month salary (annual bonus)

  • One month salary for annual clothes

  • Annual leave 18 days/year (increased to 21 days in year three, 28 days in year four and 30 days from year five).

  • Vietnam Social & Health insurance, Sick leave, Personal leave, Maternity leave and National holidays will be based on Vietnam Labor Law



JOB DUTIES/ RESPONSIBILITIES



General Responsibilities

  • Maintain an up-to-date understanding of local and international study and research regulations, train investigators on regulatory changes and ensure that these standards are implemented in all research studies.

  • Implement the Unit’s policies on the conduct of clinical trials & other research.

  • Contribute to the development of quality and efficiency within the research unit.

  • Coordinate all regulatory, logistical, training and reporting tasks associated with running a clinical study/trial.  

  • Liaise with colleagues in pharmacy, monitoring, data management and laboratory departments to ensure quality and harmonious execution of study procedures.

  • Be a part of a team that provides training for senior hospital staff on the ICH guidelines of Good Clinical Practice.

Key duties/tasks:    

  • Organise, plan and co-ordinate ICH GCP training for local study staff in Hanoi and the region.

  • Provide ICH GCP training to local study staff.

  • Supervise the transfer of documents to the central OUCRU file server.

  • Support and participate in training of new CTU staff in OUCRU procedures pertaining to CTU duties.

  • Understand relevant clinical research protocols and regulatory requirements.

  • Translate study documents (Vietnamese - English – Vietnamese) if appropriate.

  • Develop standard operating procedures to control the quality of study conduct.

  • Organize logistics of study materials including drugs, files, test kits, patient samples, data and other materials.

  • Plan, implement and coordinate all aspects of data collection, recording and source documentation, as per hospital and unit policy and ICH GCP guidelines.

  • Train study staff and investigators in protocol relevant procedures including those for laboratory samples, data collection and recording, medication and patient assessment.

  • Execute study-related administrative tasks, such as collection of data and regulatory documents, managing reimbursement for patients and study staff, filing or retrieving files, maintaining patient charts and supply inventories, etc.

  • Verify that data entered on to the CRFs is complete and consistent with patient clinical notes, known as source data/document verification.

  • Coordinate patient visit schedule as per study protocol.

  • Supervise the conduct of the study to ensure compliance with the principles of Good Clinical Practice, which will involve visiting the study sites on a regular basis.

  • Track study progress and identify problems.  Report to stakeholders as required.

  • Liaise with sponsor for monitoring/audits. Write, file and collate trial documentation and visit reports with respect to monitoring.

  • Participate in study team meetings to share experience and contribute to the knowledge of others in the team.

  • Develop the skills of a Clinical Research Monitor.  Become a member of a team of Monitors responsible for verifying the quality and compliance of research projects.

  • Visit other hospitals or community locations to deliver the above.

  • Attend career training to improve skills and update relevant knowledge.

  • Other tasks as required.



REQUIRED COMPETENCIES

Essential Criteria:

  • Medical Doctor, nurse or graduate with degree in Pharmacy, Science, Public Health or a related field.

  • Strong diplomatic skills.

  • Proven oral and written presentation skills.

  • Excellent communication and interpersonal skills.

  • High level of organizational and record keeping skills.

  • Knowledge of ICH GCP guidelines.

  • Excellent Vietnamese and English language skills.

Desirable Criteria:

  • Experience in conducting clinical trials compliant with ICH-GCP guidelines.

  • Experience conducting or managing clinical trials

  • Industry experience

  • Work experience of a Health Research Institution

  • Masters degree in health related field



Deadline for application



Interested candidates are invited to send curriculum vitae, application* and copies of relevant certificates, either by email or by post to

Bui Huyen Trang

Oxford University Clinical Research Unit Vietnam

National Hospital for Tropical Diseases

Bach Mai Hospital

78 Giai phong, Dong da, Ha noi

Email: trangbh@oucru.org

Deadline: 7 July 2017



* The cover letter should detail: What part of your education, training or employment history has best equipped you for this position?

  • Why you would make a good candidate for this position?

  • Names of two referees who can provide details of relevant experience



* Only short-listed applicants will be contacted for interview. Please no telephone contact after submitting the application

Job Details
Organisation Name: 
OUCRU
Location: 
Hanoi
Application Deadline: 
Fri, 2017-07-07