negotiable / month
Covance is actively recruiting a CRA II to be dedicated to one of our client, an international pharmaceutical company with offices based in the region of Paris (92 / RER A). If you want to be part of a dynamic team and work environment offering flexibility, career development perspective and energizing purpose, apply now! Responsibilites: 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 Prepare accurate and timely trip reportsRecruitment 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 supervisorNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedComplete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Scientific University degreeCRA training certificate desirable (SupSanté, Clinact, ILV…) Minimum of 2 years of Clinical Monitoring experience within a CRO or Pharma environmentAbility to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH GuidelinesHave a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsGood planning, organization and problem solving abilitiesAbility to work with minimal supervisionGood communication and interpersonal skillsGood analytical and negotiation skillsIf you are looking to broaden your therapeutic expertise whilst gaining exposure to a Pharmaceutical working environment this is a fantastic opportunity to seize now! We are looking forward to hearing from you and welcoming you to Covance!