2022-07-29 11:26:48

Clinical Research Associate II (CRA II) – home based

CVMarket.lt klientas

Job Description

As CRA you will be home based in Lithuania and 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.

• Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
• Completing Serious Adverse Event (SAE) reporting, processing production of reports;
• Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned;
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring.

Requirements

Candidate’s profile: • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology • Minimum of four (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) • Previous experience in monitoring oncology trials will be an asset • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries • Thorough understanding of the drug development process • Fluent in local office language and in English, both written and verbal • Excellent site monitoring and study site management skills • Ability to work with minimal supervision • Good planning and organization skills • Ability to train and supervise junior staff • Ability to resolve project-related problems and prioritizes workload for self and team • Works efficiently and effectively in a matrix environment

Company offers

In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package. EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. To apply please visit Covance career site at http://careers.covance.com/ quoting the appropriate reference number - 44909BR