Clinical Research Associate (contract)

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

._
@TG, 30112020