https://www.cvkeskus.ee/156184

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Senior Clinical Research Associate

CV MARKET´S CLIENT

Tööpakkumine on aegunud!

Tööpakkumise number 156184

Tööpakkumise number

156184

Job Description

As Senior CRA you will function as a leader for projects and assume line management responsibilities.
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; liaise with vendors; act in the project role of Local Project Coordinator or Lead CRA as assigned.


Requirements

Responsibilities:
- Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned;
- Review progress of projects and initiate appropriate actions to achieve target objectives;
- Organize and make presentations at Investigator Meetings;
- Interact with internal work groups to evaluate needs, resources and timelines;
- Act in the project role of Local Project Coordinator or Lead CRA as assigned;
- Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor;
- Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
- Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned;
- Assist with training, mentoring, and development of new employees, e.g. co-monitoring.

Required experience, skills and education:
- Excellent site monitoring and management skills;
- Minimum four years of relevant clinical research experience in pharmaceutical or CRO industries;
- Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
- Ability to train and supervise junior staff;
- Ability to work under minimal supervision;
- 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.


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.


Additional information

Apply here:


Location:
Estonia
Job type:
full-time, employee
Expiration date:
20. juuli 2008
Published:
20. juuni 2008

CV MARKET´S CLIENT

is probably enhancing your quality of life without you even knowing it. We play an important role in bringing new therapies to market by helping to turn raw compounds into safe, effective, and approved drugs that help people live longer, more productive lives.

Our mission - bringing medical miracles to market sooner - impacts the lives of millions of people all over the world. Our current growth of Clinical Development Services (CDS) in Eastern European countries brings new opportunities not only for clinical roles, but also other business functions. At the moment we are looking for: