Clinical Research Associate II/Senior
Here at INC Research/inVentiv Health we are currently recruiting for a CRA II or Senior CRA to be based in our office in Warsaw, Poland (with possibility to be home-based after probationary period)
The Clinical Research Associate II will perform clinical monitoring activities following study guidelines, SOPs, and applicable regulations. This position is responsible for ensuring the overall integrity of assigned studies through the use of independent judgement to assess adherence to study protocol and regulations.
* Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
* Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.
* Ensure compliance and understanding of study requirements by site contacts.
* Interpret data to identify protocol deviations or major risks to data integrity.
* Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff
* Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
* Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
* Review and verify case report forms and other clinical data for completeness and accuracy.
* Monitor patient safety, identify and address any protocol deviations.
* Generate queries and manage resolutions with site personnel.
* Participate in the identification and selection of investigators and clinical sites.
* Work with junior staff on training, guidelines, and processes.
The ideal candidate will need the following experience / skills to be considered:
* Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
* Travel required (up to 40%)
* Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
* Strong organizational skills
* Must demonstrate good computer skills.
This position is full time and is offered through permanent employment with INC Research/inVentiv Health. Details on request.
If you have the required experience for this position and are eligible to work in the required location then please apply by CV or contact Magdalena Raczyńska on
To find out more about our company and search and apply for other open jobs please visit our website http://www.inVentivHealthclinical.com
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.