Clinical Research Associate/Senior Clinical Research Associate

Responsibilities:

 Clinical Trial Start-up: assist Clinical Research Manager with preparation from the beginning of clinical trial, including communication with sites, collection of regulatory documentations, preparation of documentations for EC submission, customization of trial required documentations and file for sites, attendance of Investigator Meeting;

Plan and perform site visit and management: preparation and conduct of site initiation, monitoring and close-out visit in accordance with GCP, protocol, ALK SOP and relevant regulations to ensure the subject’s safety and quality of the trial;

Act as regional CRA lead to solve issues independently;

Track the progress of the trial, availability of trial required materials in a timely manner

 Coordinate with internal departments and CRO;

 Customer Maintenance: Consolidate positive relationship with principal investigators;

Qualifications:

Bachelor degree or above in Medicine or related discipline;

 At least 2 years experience for CRA, 3 years for senior CRA

 Familiarity of GCP and clinical trial process for biological products and/or western medicines in China;

Strong oral/written communication and coordination skill;

 Acted as a good team player with demonstrated independent working ability;

Detail-oriented

 Fluent verbal and written English skill

As the world biggest immunotherapy company for allergies (asthma/rhinitis), we will offer you:

  very competitive package

Unique opportunity to work with first class opinion leaders in China for clinical co-operation

Overseas training and exchange opportunities

Business oriented development for each personnel – career development in both clinical trial and medical marketing