Clinical Research Associate - Malaysia

Company Name:

Covance Asia

job Description:

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 visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring Responsibilities

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy


Prepare accurate and timely trip reports
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work 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
Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of 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
Assist with training, mentoring, and development of new employees, e.g. co-monitoring
Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management

 
Experience and Requirements for Clinical Research Associate II:

Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Good planning, organization and problem solving abilities
Ability to work with minimal supervision
Good communication and interpersonal skills
Good analytical and negotiation skills
computer competency
Fluent in local office language and in English, both written and verbal
Works efficiently and effectively in a matrix environment

Preferred:

One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred

 
Experience and requirements for Sr. Clinical Research Associate:

Minimum of four (4) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
In lieu of the above requirements, candidates with > four (4) years supervisory experience in a health care setting and three (3) years clinical research experience in the pharmaceutical or CRO industries (including monitoring) may be considered
Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Excellent site monitoring skills
Excellent study site management skills
Excellent registry administration 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
Excellent verbal and written communication skills
Ability to train and supervise junior staff
Ability to resolve project-related problems and prioritizes workload for self and team
Ability to work within a project team
Works efficiently and effectively in a matrix environment

Preferred:

One (1) or more year’s additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
Local project coordination and/or project management