You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.
This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
As CRA you will be 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; Interact with internal work groups to evaluate needs, resources and timelines; Assist with training, mentoring, and development of junior employees, e.g. co-monitoring; Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
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 Few years of relevant clinical research experience in pharmaceutical or CRO industries will be considered (including pre-study, initiation, routine monitoring and closeout visits) Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries Experience within oncology therapeutic area (preferable) Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Excellent site monitoring skills Excellent study site management skills Excellent registry administration skills Ability to work with minimal supervision Good planning and organization skills Good computer skills with good working knowledge of a range of computer packages Excellent verbal and written communication skills Ability to resolve project-related problems and prioritizes workload for self and team Fluent Romanian and English language skills
THERE IS NO BETTER TIME TO JOIN US!
Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.
Key words: Clinical trial, Clinical research, research monitoring, on-site monitoring, remote monitoring, clinical operations, GCP, ICH, SOP, CRO, Clinical Research Associate I, II, Senior CRA, Clinical Research Associate 1, 2, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Monitor, CRA I,II, Senior, CRA 2, CMA, CTA, in-house monitor, in-house CRA, home based, office based, Romania, Bucharest