Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster. If that is your passion, we have a place for you. We are looking for suitable individuals to fill the position of :
Senior / Clinical Research Associate (Kuala Lumpur)-1109553Job Responsibilities
- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- May provide assistance to the CTL with design of study tools, documents and processes.
- Degree in Science, with a major in Pharmacy, Biological / Life Sciences or Nursing from a recognised tertiary institution.
- Minimum 2 years relevant experience in the pharmaceutical / CRO industry
- Good knowledge of drug development process, clinical trial monitoring procedures, GCP guidelines and medical terminology.
- Excellent analytical and problem-solving skills.
- Effective organizational, verabla/written communication and interpersonal skills.
- Able to travel when required.
Please apply online via www.quintiles.com/careers
