A Leading European Global pharmaceutical company.
CRA / Senior CRA.
Responsible for timely monitoring for each site in charge of specific trial supported by CRM in compliance with Quality system and SOPs.
Follow all the necessary procedures required by GCP, and protocols.
Commit to preliminary research as a Monitor. Such request for participation in a clinical trial, contract, supply of trial products, provision of safety information related to SAEs, etc., in a timely and prompt manner.
Make necessary preparations for GCP inspection and document compliance review.
Qualifications - Pharmacy, Nursing, Clinical Lab. Technology, and other related scientific degree
Education - Scientific bachelor’s degree. (Advance degree preferred)
Language skill - Japanese Native, at least Business level English (reading, writing, speaking)
For Senior CRA:
At least 10 years of CRA experience
Participation in joint global clinical trials
At least 3 years’ experience
Knowledge of clinical development and GCP
Basic to intermediate medical and science knowledge