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