Ref #: 32880

Employment type: Permanent - Full-Time

Location: Kuala Lumpur

Posted: 08-Oct-2021


*Do you love monitoring and being an active part within drug development?

Then look further, this is the role for you!

Our client is looking to recruit an experienced CRA who can demonstrate strong Oncology clinical trial monitoring of phase II-III studies within the industry.

The Role and your Responsibilities:
• To perform all aspects of CRA duties from site selection, site initiation, through to site routine monitoring visits through to close-out visits and database lock.
• Contributes to Case Report Form (CRF) design and clinical trial document development as they pertain to clinical monitoring activities (i.e. operating manuals, monitoring guidelines, etc.);
• Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/ Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
• Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
• Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
• Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
• Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;

What is Required:
• Degree (BA/BS/BSc) in life sciences or qualified nurse
• At least 12/18 months CRA experience gained within the industry as a Clinical Research Associate (CRA) either in Clinical Research Organisation (CRO) or pharmaceutical industry or investigational site
• Clinical Trial Assistants / Study Coordinators with ISR product experience are welcome to apply!
• Experience of clinical trial set up and contract negotiation preferred, but not essential