Clinical Specialist ★ 4.2

Department

Clinical Trials Unit

Location

Oxford University Clinical Research Unit, Ha Noi, Viet Nam

Hours of work

Full-time. Working hours are 37.5 hours per week.

Tenure

Initially for 1 year, including a 2-month probation period, with the possibility of extension.

Reporting to

Manager of CTU

Vacancy reference

JDHAN-0525-006

Background

The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit, with sites offices in Ho Chi Minh City and Hanoi in Vietnam, Jakarta in Indonesia and Kathmandu in Nepal. In Vietnam, we are hosted by the Hospital of Tropical Diseases (HTD) in Ho Chi Minh City, and the National Hospital for Tropical Diseases (NHTD) in Hanoi. OUCRU Nepal has partnerships with the Patan Academy of Health Sciences and Patan Hospital, and OUCRU Indonesia exists in partnership with the University of Indonesia. As a Wellcome Trust Africa Asia Programme, we have received considerable support from the Wellcome Trust since our establishment in 1991.

OUCRU’s vision is to have local, regional and global impact on health by leading a locally driven research programme on infectious diseases in Southeast Asia. Priority is given to health issues important to the hospitals where we work, and to the countries as a whole where we operate: Vietnam, Indonesia and Nepal. All work is intended not only to benefit the patients seen daily at our host hospitals, but also to help improve patient care.

OUCRU employs approximately 320 people across Viet Nam and has an average annual budget of USD 12mil.

Please see more information on OUCRU website: www.oucru.org

Job summary

An Ethics and Contract Specialist will support studies through the required ethical and regulatory approvals and study project agreement, help to prepare study documentation, track study progress, maintain approvals/documentation during the study, and liaise with the study sites to ensure the study is run in compliance with international guidelines and local regulations. The post holder will contribute to the continued growth and development of the CTU team.

Key responsibilities and tasks

· Responsible for supporting all Science and Ethics committee submissions (OxTREC, WorkTribe, Studyline and local ECs):

o Conducting protocol and study documents pre-reviews:

§ Work with the study staff for each new study to ensure the protocol and procedures comply with the applicable local and international regulatory standards and applications comply with requirements of applicable committee.

§ Review clinical trial protocols in order to identify inconsistencies, errors and omissions.

o Conducting the submission and tracking of regulatory and ethical applications for clinical research to relevant local and international bodies.

o Being key contact to communicate IRB decisions and rationale to investigators.

o Maintain regulatory filing of essential documents for each study in accordance with the principles of Good Clinical Practice.

· Maintain an up-to-date understanding of clinical trial regulations and ethics, both local and international.

· Support the SAE reporting procedure, help PIs and coordinators to liaising with local ECs and MoH to send the SAE reports as required by the local ECs and MoH guideline

· Contribute in the development of study and site procedures for good research governance.

· Help study staff to develop appropriate ways to document all processes in a research study

· Act as the primary contact for local and national regulatory bodies regarding clinical trials.

· Perform general administrative duties as needed.

· Verify study document translation (English – Vietnamese)

· Contribute to the development of CTU systems, procedures and documentation, especially those relating to governance processes.

· Support to check and update the documents in CTU OUCRU sharepoint

· Attend career training to improve skills and update relevant knowledge

· Standardize the study project agreement to comply with the regulation and requirements

· Support to develop the study payment framework

· Support to develop the standard of procedures related to study project agreement, study payment and study budget management

· Support to the preparation of researches grant application budgets.

· Be involved in the development of research projects budgets and reseach contracts/agreements planning during the initiation and implementation stages at local sites.

· Prepare and review all research contracts/agreements with collaborators.

· Translate or verify the translation of research contract/agreement (ENG-VN-ENG). Ensure the proper and timely execution of these documents for research implementation.

· Actively liaise with PI and the study team to develop project agreement and other research related contracts/agreement, to decide reasonable payments and set up contract payment terms for the clinical studies.

· Closely work with OUCRU Finance Department to maintain correlation between the contracts and financing system of the Department and the CTU.

· Read and understand the relevant regulations/requirements relating to study finance or payment

Other tasks as required by CTU manager.

Selection criteria

Essential criteria:

· Degree in Science, Pharmacy, Medicine, Nursing, Public Health or related field.

· Excellent Vietnamese and English language skills.

· Proven oral and written presentation skills.

· Diplomatic communication and interpersonal skills.

· High level of organizational and record-keeping skills.

· 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

Preferred criteria:

· Experience in conducting, coordinating, monitoring or quality-assuring of clinical research.

Benefits

- Contracted salary:

- Grade: RS3/IC3

- Salary ranges: $ 1,042 - $ 1,147 gross per month

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

- Two months’ salary for annual bonus and clothes

- Annual leave 18 days each year for the first year

· Other responsibilities and