Covance Bulgaria is looking for Clinical Research Associate II!
Nr ref.: /JOBS.pl
COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
We are currently seeking a proactive, driven Clinical Research Associate II to join our expanding CoSource team in Bulgaria.
About the job:
• 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. • General On-Site Monitoring Responsibilities (a) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study. (b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements. (c) 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. (d) Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy. (e) Prepare accurate and timely trip reports.
• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered • 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.
• Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits). In lieu of the above requirements, candidates with three (3) years of site management and/or registry administration experience will be considered. • 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 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
THERE IS NO BETTER TIME TO JOIN US!
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.