Covance

Clin Res Assoc II

Job Location(s) MY
Job Number
2018-16761
Job Category
Clinical Research Associate
Position Type
Full-Time

Job Overview

Due to expanding business, we are looking for an experienced CRA to join our Malaysia operations. This is a great chance to build your experience with on global studies with an aggressively growing CRO.

 

Essential Job Duties:

- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visit; liaise with vendors; and other duties, as assigned

- - Responsible for all aspects of site management as prescribed in the project plan

- General On-Site monitoring Responsibilities as per company requirements

- Prepare accurate and timely trip reports

- Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

 

- Undertake feasibility work when requested

- Conduct, report and follow-up on Quality Control Visit (CQC) when requested

- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

- Negotiate study budgets with potential investigators and assist the Covance Legal department with statement of agreements as assigned

- Complete process of SAE reporting, process production of reports, narratives and follow up SAEs

- Independently perform CRF review, query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management

- Perform the other duties as assigned by management

Education/Qualifications

Minimum required:

- minimum of 3 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)

- Have cardiology, oncology and/or psychology studies background is benefit

- Thorough knowledge of ICH-GCP including good understanding of local regulatory requirements

- Thorough understanding of the drug development process

- Fluent in English and local languages, both in written and verbal

- Have a full understanding of SAE reporting, process production of reports, narratives and follow up of SAEs

- Ability to travel >70% of the time

- Equipped with site monitoring skills

Ability to work with minimal supervision

- Good planning and organization skills

- Good computer skills with good working knowledge of a range of computer packages

- Ability to resolve project-related problems and prioritize workload for self and team

- Ability to work within a project team

- Work efficiently and effectively in a metrics environment

Experience

- minimum of 3 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)

- Have cardiology, oncology and/or psychology studies background is benefit

 

 

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Tell Us About Yourself

Not ready to apply? Connect with us to join our talent community.