Clinical Research Associate (I, II or Senior)
Here at INC Research/inVentiv Health we are currently recruiting for a Clinical Research Associate to work with one of the largest and most successful Pharmaceutical companies in the world. Employment would come from INC Research/inVentiv Health and you would be outsourced to this client.
* Identifies new potential investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel and other medical contacts. Assess potential Investigators and their sites. Documents the visit and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators.
* Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements.
* Reviews site activities and quality through on-site visits in addition to emote management capabilities.
* Ensures safety and protection of study subjects according to the monitoring plan, SOPs and ICH/GCP Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.
* Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems.
* Prepares and submits written reports, both monitoring and administrative, in timely, accurate, consistent, professional and objective manner.
The ideal candidate will need the following experience to be considered:
* Minimum six months prior independent clinical monitoring experience
* Valid CRA Certificate
* Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
* Ability to travel for monitoring visits
* Knowledge of GCP/ICH Guidelines and other applicable regulatory requirements
* Strong organizational skills
* Must demonstrate good computer skills.
There are many benefits available to employees of INC Research/inVentiv Health. They include competitive compensation and benefits (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