• 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
• Responsible for all aspects of site/registry management as prescribed in the project plans
• 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
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
Typically required :
• Minimum of one (1) year of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Fluency in Estonian and English
• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, 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 knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process
• Good planning, organization and problem solving abilities
• Good communication and interpersonal skills
• Available for travel up to 40% to 60% of the time, including overnight stays as necessary
Typically required :
• University/college degree (life science preferred), or certification in a related allied health profession (e.g., nursing certification, medical or laboratory technology)
• In lieu of the above, candidates with at least two (2) years of relevant clinical research experience in pharmaceutical or CRO industries will be considered as well
• A valid driving license.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.