Clin Res Assoc II
- Employer
- Labcorp
- Location
- Prague, Czech Republic
- Salary
- Competitive
- Start date
- 8 Oct 2019
- Closing date
- 25 Oct 2019
View more
- Discipline
- Clinical Research, Clinical Research Associate
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Covance is looking to hire a CRA II/ Senior CRA inCzech Republic( in house role with Covance)
With the support of exceptional people and an energized purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalized development planning.
Reponsibilities:
- 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
- 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, of new employees, e.g. co-monitoring
- Coordinate 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
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- minimum of 2 years of Clinical Monitoring experience.
- 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
- 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
Company
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.
- Website
- https://careers.labcorp.com/global/en
- Location
-
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
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