2023-04-13 14:47:21

Clinical research associate II or senior CRA

CVMarket.lv klients

Job Description

For our CoSource department in Latvia we are currently looking for a home based position. 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. Responsibilities: • Site administrating and site monitoring responsibility for clinical studies according to 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 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.

Requirements

Required skills, experience and education: • Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries nd minimum 1 year within oncology therapeutic area; • University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology); • Fluency in local and English language; • Understanding of the clinical trial process; • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements; • Thorough knowledge of monitoring procedures.

Company offers

We Offer: Covance's ongoing success offers team members unsurpassed growth and career development opportunities. 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. There is no better time to join us! For more information or to apply: Please visit Covance career site at http://careers.covance.com/ quoting the appropriate reference number -46046BR, or follow the link