For a confidential consultation or more information please call Antony on 00 44 1142 701 741 or email me amoran@acr-uk.com.
FANTASTIC OPPORTUNITY FOR CRA I LEVEL INDIVIDUALS TO PROGRESS THEIR CAREER!
My client is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.
In the framework of our steady growth, they are constantly looking for an enthusiastic and experienced....
Clinical Research Associate's
who will...
be responsible for all aspects of study site monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaise with vendors and other duties
ensure the study staff has received the 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
be responsible for all aspects of site/registry management as prescribed in the project plans
be responsible for recruitment of potential investigators, involvement in EC submissions and notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
They offer you the opportunity to develop your career with an international organization : to pursue further training and to take advantage of their flexible conditions and attractive remuneration package.
Required:
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
• In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
• Thorough knowledge of monitoring procedures
• Basic understanding of the clinical trial process 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.
For more information call Antony @ ACR on 00 44 1142 701 741 or email amoran@acr-uk.com.
I look forward to hearing from you.
