Ref #: 35849
Employment type: Permanent - Full-Time
Location: Kuala Lumpur
Posted: 17-May-2021
Description
If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance. We are hiring a Senior Clinical Research Associate I to work closely with our client, a leading pharmaceutical company.
Overview:
As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.
Description:
* Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
* Acts as primary local company contact for assigned sites for specific trials.
* Attends/participates in investigator meetings as needed.
* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
* Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
* Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
* Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
Requirements:
* A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
* Must have experience in Clinical Research or equivalent qualification
* Usually 0-2 years experience monitoring on site
* Specific therapeutic area experience may be required depending on the position.
* Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
* Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
* Proficient in speaking and writing the country language and English.
* Good written and oral communication skills.
Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.
#CRAjob
Overview:
As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard operating procedures. In this role you will be a decision maker, solving problems independently or as part of the client and ICON team.
You will be managing competing priorities, supporting the on-site team, ensuring investigators follow the clinical trial protocol, providing training, and most importantly, motivating the team to ensure high quality results.
Description:
* Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
* Acts as primary local company contact for assigned sites for specific trials.
* Attends/participates in investigator meetings as needed.
* Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
* Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
* Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
* Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
* Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
* Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints).
Requirements:
* A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
* Must have experience in Clinical Research or equivalent qualification
* Usually 0-2 years experience monitoring on site
* Specific therapeutic area experience may be required depending on the position.
* Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
* Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
* Proficient in speaking and writing the country language and English.
* Good written and oral communication skills.
Why join the DOCS team at ICON?
Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.
#CRAjob