Job Description
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 (for CRAs II);
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II).
Requirements
Required skills, experience and education:
- Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries;
- 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
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.
THERE IS NO BETTER TIME TO JOIN US!
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Experience
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EEO Employer
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.
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