Clinical Research Assistant - Ukraine
Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.
Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.
We are currently seeking a pro-active Clinical Research Assistant to join our expanding CoSource team in Kiev.
Essential Job Duties:
o Act as contact for project team and study sites
o Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
o Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
o Assist with the management of study supplies and organize shipments
o Create, update, track, and maintain study-specific trial management files, tools, and systems.
o Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)
o Coordinate meetings with clients, investigators, and project team, including taking minutes.
o Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
o Provide input in writing Monitoring Conventions as assigned
o Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
o General On-Site Monitoring Responsibilities:
§ Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)
§ Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates, Project Managers or Project Directors
o Perform other duties as assigned by management
Education / Qualifications:
· 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 proven relevant clinical research experience in pharmaceutical or CRO industries may be considered
· Basic understanding of biology and biological processes
· Good organizational and time management skills
· Good communication skills, oral and written
· Exhibit general computer literacy
· Works efficiently and effectively in a matrix environment
· Fluent in local office language and in English, both written and verbal
· Proven experience in a related field, (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing)