Ref #: 26794

Employment type: Permanent - Full-Time

Location: Malaysia

Posted: 10-Feb-2021

Description

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


What is Offered
* Opportunity to work with Global Tier 1 Pharma Company
* Vibrant working environment
* Excellent Opportunity for Career Progression


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 or equivalent
• 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
• Experience in clinical monitoring of phase II-III clinical trials preferred (other therapeutic areas could be considered)
• Experience of clinical trial set up and contract negotiation preferred, but not essential