Experience

Oxford University Clinical Research Unit

• Vietnam
• Research Services
• 200 - 300 Employee

• Sr. Clinical Research Coordinator

  • Dec 2022 - Present



Eijkman Oxford Clinical Research Unit

• Jakarta, Indonesia

• Clinical Research Coordinator

  • Dec 2021 - Nov 2022



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Manager, Resource and Site Network

  • Apr 2015 - Dec 2017

  • Line reporting for several direct reports (Clinical Research Associates and Regulatory Start up Specialists), review and appraise direct reports’ annual performance, and manage clinical operation management for Indonesian office (sharing with other Manager). Achievement: Coached direct reports regarding monitoring skills as well as soft skills (communication and time management). Received approval from Senior Management on promoting four direct reports into next grade of career.• Oversee Regulatory and Study Start up in Indonesia, and leverage start up delivery as per contracted timeline and maintain customer satisfaction. Achievement: Initiated written Regulatory and Start up Manual for Indonesia by oversee the author team compiled all regulatory aspect including tips and trick while delivering start up in Indonesia. The manual was finalized by end of 2017 and used as guidance for upcoming RSU specialist.• Manage relationship with hospital management for smoothen the delivery of research conducted in respective hospital. Achievement: Recognised hospital management policy regarding clinical research conducted as reference on smoothen research conducted in the respective hospital. • Assess the quality and integrity of research site practices related to the proper conduct of the protocol and adherence to applicable regulations. Show less

• Sr. Clinical Research Associate

  • Sep 2010 - Mar 2015

  • Perform site selection, initiation, monitoring, site management and communication (including study training to assigned sites) and close-out visits in accordance with contracted scope of work and good clinical practice for a variety of protocols, sites and therapeutic areas.Achievements: Achieved 100% of patients target of recruitment within the agreed timeline (three months). • Managed Safety Reporting to Regulatory done in appropriate manner and timeline. Familiar with Indonesian Safety Reporting process, timeline and documentation based on BPOM requirement.• Managed to smoothen financial process and communicate with site which resulted resolution of payment issue and maintain good relationship with sites.• Local Project Manager: support team with management of the research including protocol, informed consent review, budgeting and adapting resource scope of work, managing research conduct until closing. May provide assistance to less experienced clinical staff. Show less

• Clinical Research Associate

  • Sep 2007 - Aug 2010

  • Perform site selection, initiation, monitoring, site management and communication (including study training to assigned sites) and close-out visits in accordance with contracted scope of work and good clinical practice for a variety of protocols, sites and therapeutic areas.Achievements: Achieved 100% of patients target of recruitment within the agreed timeline (three months). • Managed Safety Reporting to Regulatory done in appropriate manner and timeline. Familiar with Indonesian Safety Reporting process, timeline and documentation based on BPOM requirement. Show less



GleneaglesCRC Pte Ltd

• Greater Jakarta Area, Indonesia

• Study Coordinator

  • Mar 2007 - Aug 2007

  • Responsible for screening and interviewing patients for clinical trial. Provide support to investigators on recruitment, review medical chart for patient eligibility, scheduling patients visit, screening and study procedures. • Responsible for screening and interviewing patients for clinical trial. Provide support to investigators on recruitment, review medical chart for patient eligibility, scheduling patients visit, screening and study procedures.



PT. Claris Lifesciences

• Jakarta, Indonesia

• Regulatory Specialist

  • Aug 2006 - Oct 2006

  • Responsible for screening and interviewing patients for clinical trial. Provide support to investigators on recruitment, review medical chart for patient eligibility, scheduling patients visit, screening and study procedures. • Responsible for screening and interviewing patients for clinical trial. Provide support to investigators on recruitment, review medical chart for patient eligibility, scheduling patients visit, screening and study procedures.