The Eijkman-Oxford Clinical Research Unit (EOCRU) in Jakarta opened in 2008
with the signing of a memorandum of understanding between the Eijkman Institute
for Molecular Biology and the University of Oxford, to conduct collaborative
research on infectious diseases impacting the health of Indonesians and
residents of other Southeast Asian nations. University of Oxford also has a
partnership (MoU) with Universitas Indonesia, and they jointly established the
Universities of Indonesia and Oxford Clinical Research Laboratory (IOCRL) which
is a facility dedicated to supporting collaborative clinical research between
the universities. EOCRU is also part of the Oxford Tropical Network with
research units in Africa, Asia and UK, and operates under the auspices of the
Oxford University Clinical Research Unit in Vietnam.
Clinical trials of chemotherapeutics, diagnostics and vaccines for tropical
infections of public health importance in Indonesia, principally malaria,
tuberculosis, antimicrobial resistance, and other emerging and neglected
tropical diseases, form the core of EOCRU’s activities, with associated
epidemiological, laboratory, and clinical research. EOCRU aims to have a
positive and significant impact on the prevention, diagnosis and treatment of
infectious diseases to improve patient care in Indonesia and the region. This
is being achieved via an expanding long-term research programme with our local
hosts and partners, contributions to research training, and public engagement
with science. Current EOCRU core staff includes 3 Oxford-employed expatriate
scientists, 10 Indonesian scientists, 6 administrative and finance support
staff, and approximately 30 clinical trials support staff.
In conducting their work in Indonesia, EOCRU is assisted by Alliance for
Emerging and Re-emerging Disease Threats in Asia Foundation (ALERTAsia), a
local foundation assisting in research grant management and capacity building
for local researchers.
Through ALERTAsia we are seeking a qualified and experienced Clinical Research
Operations Manager to support our growing portfolio of clinical research, The
post-holder’s primary responsibility is overseeing and developing clinical
trials operations of high quality and efficiency within EOCRU, which are in
line with the Good Clinical Practice (GCP) and international regulatory
standards. This vacancy offers an exciting opportunity for an active
professional to take a leading role in contributing to the further development
and professionalization of the clinical research capacities with EOCRU and its
partners. The post-holder will be responsible for team management and assure
the successful execution of all EOCRU clinical research/studies
Job Description
The Clinical Research Operations Manager will have the following
responsibilities:
Lead and develop the clinical trials operations team consisting of study
coordinators, study clinicians, pharmacists, data managers, and laboratory to
ensure execution of high quality clinical research studies.
Oversee the clinical research governance team consisting of trial
administrators and monitors to ensure that all research complies with national
and international regulations. This includes maintaining an up-to-date
understanding of the applicable trial regulations, train investigators on
regulatory changes and ensure that these standards are implemented in all
research activities.
Contribute to the decision-making process for how clinical trials are optimally
managed at the Unit together with the Head of Unit and the Scientific Committee.
Advise within the Unit and all collaborators on all matters relating to
operational support of planned and ongoing clinical trials including
management, monitoring, and evaluation.
Implement the Unit’s policies on the conduct of clinical trials.
Ensuring quality and consistency across all clinical research conducted within
the clinical operations team
Undertaking any other duties consistent with the grade as requested by the Head
of Unit.
Frequently liaise/meet with the Principal Investigators, investigators and
EOCRU staff.
Work with the trial staff at all sites to ensure that studies are executed in
compliance with the protocol and applicable local and international regulatory
standards.
Support EOCRU and site staff to:
Implement required training for research staff, particularly in the areas of
human subjects’ protection, protocol related procedures and good clinical
practice.
Develop data and operational tools to deliver research studies including
protocol specific Case Report Forms, Standard Operating Procedures, Data
Management Plan, DSMB Charter, Informed Consent Forms, Monitoring Plan,
Regulatory documentation and training.
Design standard procedures for study related activities including laboratory,
clinical and data management processes.
Oversee the pharmacy, data management and logistics for trials.
Ensuring reports are provided to the necessary stakeholders in a timely manner
Achieve research targets and address operational issues.
Benefits
The selected candidate will receive a three months contract and, if can show
professionalism and work dedication, a possibility to receive long term
contract and remuneration package that includes annual leave, sick leave, THR,
optional private medical cover, BPJS Kesehatan, and not to mention fully paid
income tax and BPJS Ketenagakerjaan (JAMSOSTEK). The salary shall be
competitive and dependent upon qualifications and salary history.
Job Requirements
Qualifications
Any higher level education (Bachelor of Science, Medical Doctor, Masters or PhD
in Science, Public Health) or a related and equivalent degree.
Project management experience with at least three years experiences of managing
a large team.
Significant experience in and in depth understanding of all aspects of clinical
trials and in the conduct of clinical trials compliant with ICH-GCP guidelines.
Strong diplomatic skills.
Actual or near fluent in spoken English and Bahasa Indonesia
Proven oral and written presentation skills.
Excellent communication and interpersonal skills.
High level of organisational and record keeping skills.
Desirable Criteria:
Experience conducting or managing clinical trials in Indonesia or South East
Asia.
Work experience in a health research institution.
How to Apply
Application requirement (Cover Letter, CV, three name and address of
professional referees, and your salary history) should be sent via e-mail to:
hro@xxxxxxxxxxxxx <mailto:hro@xxxxxxxxxxxxx>. Please quote the reference
“EOCRU-CROM” on your email subject. Shortlisting candidates will start
immediately. Please submit your application by 9 November 2019; 0500 p.m
Thank you!