Clinical Research Associate (contract)

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PT Kalbe Blackmores Nutrition
Position: Clinical Research Associate (contract)

PT Kalbe Blackmores Nutrition is a joint venture between KALBE and Blackmores, for detailed information about our company please visit www.blackmores.co.id

Responsibilities:

  • Deliver clinical support to Investigators in clinical studies, coordinate clinical trial activities, and be responsible for all major stages of study development, execution, monitoring, and close-out.
  • Manage quality controls, execution of clinical protocol and data management for a number of clinical trials at multiple sites, ensuring study compliance with Good Clinical Practices (GCPs), all applicable regulations, and contractual requirements.
  • Participates in site/investigator selection, study initiation and termination activities, establishes trial sites, and trains site staff as required.
  • Monitors the conduct, recruitment, and progress of the studies to ensure compliance with established protocols, appropriate research methodology, and study timelines.
  • Ensures data integrity through source data verification and monitoring process; and/or remote monitoring and ensuring site compliance with established protocols, appropriate research methodology, and study timelines
  • Manages/coordinates all biospecimen collection activities, shipping kit and buffer storage, inventory, and disposition requirements including Investigational Product (IP) management and other trial materials


Requirements:

  • Professional Degree in Pharmacy from reputable university
  • Fluent in English (both written and speaking)
  • Able to work independently and collaborate with various role players, as this position will coordinate with Blackmores team in Singapore
  • Prior experience of working in investigator site management of at least 4 years of independent CRA experience; including conducting monitoring visits from either a pharmaceutical company or a CRO environment
  • Prior experience in monitoring trials in the community setting, related to clinical nutrition research
  • Solid knowledge of GCP, national and international regulations and a sound understanding of how they apply to you
  • Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative clinical trials
  • IT savvy, responsive, responsible, committed and matured mindset
  • Preferably trained in ICH-GCP principles demonstrated with the training certificate
  • Placement on PT Kalbe Blackmores Nutrition


Send your CV to mira.sulistyati@blackmores.co.id

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@TG, 30112020

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