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
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