[newdevjobsindo] Urgently Required: Clinical Research Coordinator for Oxford University Clinical Trial Unit Indonesia (deadline date: 29 June 2024)

Juni 12, 2024   Comment  

As of September 2022, the Oxford University Clinical Research Unit in Indonesia (OUCRU Indonesia) operates in partnership with the Faculty of Medicine Universitas Indonesia after having been known as the Eijkman Oxford Clinical Research Unit (EOCRU) since 2008. OUCRU Indonesia is part of the Africa Asia Programme Vietnam, sponsored by the Wellcome Trust, and governed by the Centre for Tropical Medicine and Global Health at the Nuffield Department of Medicine, University of Oxford, United Kingdom. OUCRU in Indonesia and Vietnam, along with their many local and international partners, conduct biomedical, clinical, and epidemiological research on infections impacting the health of people living in Southeast Asia and beyond.

In conducting their work in Indonesia, OUCRU ID 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 Coordinator to be responsible in project management of the clinical trial/research assigned to him/her, to ensure the timely and on-budget implementation, and compliant clinical trial. S/He will be responsible to oversee the implementation and coordinate the activities of different roles and stakeholders both at OUCRU ID, sponsor and collaborators.  The worksite is the Faculty of Medicine Universitas Indonesia campus at Salemba in Central Jakarta.

 

Roles and Responsibilities

·       Develop and maintain clinical trial implementation plan, timelines, budget and progress reports as required by OUCRU ID, sponsors and collaborators. 

·       Ensures milestones and project work are met within agreed times and budgetary framework.

·       Liaise with Finance and Operations regarding the budget management and procurement process.

·       Draft and monitor the progress of clinical research agreements with collaborators, in collaboration with Operations Manager.

·       Manages relationship effectively with the members of each clinical trial/study team, sponsor, relevant authorities and sites to ensure the successful implementation of each study/trial.

·       Act as the liaison between study sites, the clinical trial support facility, and the Principal Investigator ensuring open and efficient communications of essential information.

·       Organizes training, meetings and other activities with study staff, through a combination of meetings in person and via teleconference to facilitate communication and ensure study milestones are achieved in timely manner

·       Support the regulatory team in the preparation of clinical trial applications, agreements and responses to, and reports for the relevant authority bodies and ethics committee.

·       Conduct oversight including self-monitoring and evaluation of the implementation of clinical trial at site level, and ensure all deviations and/or finding is reported and addressed in timely manner.

·       Conduct site initiation and close out visits.

·       Maintains accurate documentation of all study-related activities in accordance with applicable standards and regulations.

·       Ensures clinical trial compliance at all times with protocol and applicable regulatory, national, and internationally accepted guidelines for Good Clinical Practice in research (ICH-GCP).

·       Other tasks as assigned or delegated by the line manager.

 

Qualifications

Education and Experience

·       Pharmacist or Medical Doctor or MSc/PhD in Life Sciences

·       Minimum of 2 years of clinical trial and/or drug development experience

·       At least 1 years of clinical research project management/coordination as Clinical Research Associate or Monitor with clear evidence of delivery.

·       High level of clinical research conduct requirements and skill

·       Excellent English scientific writing and communication skills

·       Ability to work effectively in matrix environment

 

Required Knowledge And Abilities

·       Good Clinical Practice (GCP).

·       Good Pharmacovigilance Practice (GVP).

·       Relevant local and global Clinical Trial Regulations. 

·       Familiarity with local diseases guidelines and patient management standards.

·       Project management skill.

·       Procedural document writing and management.

·       Risk Management and Mitigation, including Root Cause Analysis and CAPA development.

·       Organization skills.

·       Interpersonal skills and problem-solving capabilities.

·       Strategic agility.

·       Strong verbal and written communications skills.

·       Learning agility and 'scalability' to take on additional responsibility.

 

 

Benefits:

The selected candidate will initially receive a 12 months' contract with a possibility to receive a contract extension. Remuneration package that includes annual leave, sick leave, THR, compensation money, optional private medical cover, BPJS Kesehatan, and not to mention fully paid income tax and BPJS Ketenagakerjaan (JAMSOSTEK). The salary shall be competitive.

 

The successful candidate will work in a dynamic team of clinicians, academics, scientists and research support teams from diverse renowned, international centres.

 

 

How to Apply:

Application requirements (Cover Letter, CV, three names and address of professional referees, and your salary history) should be sent via email to: hro@alertasia.org . Please quote the reference "OUCRU ID CRC_[Your Name]" on your email subject.

 

Please submit your application no later than Saturday, 29 June 2024.