Clinical Research Associates – Czech Republic

Covance is one of the world's most dynamic drug development services companies, providing integrated, tailored solutions to the pharmaceutical and biotechnological industries.

We are currently looking for: Clinical Research Associates (CRA) in Czech Republic with Oncology experience.

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:

• Responsible for all aspects of site management as prescribed in the project plans;
• General On-Site Monitoring Responsibilities:
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study;
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements;
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data;
• Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy;
• Prepare accurate and timely trip reports;
• Responsible for all aspects of registry management as prescribed in the project plans;
• Undertake feasibility work when requested;
• 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;
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned;
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management;
• Assist with training, mentoring, and development of new employees, e.g. co-monitoring (for CRAs II and Senior CRAs);
• Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned ( CRAs II and SCRAs);
• Perform other duties as assigned by management;

Required skills, Experience and education:

• University/college degree (life science preferred), or certification in a related allied health profession;
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements;
• Minimum of 6 months up to 4 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits);
• Experience in monitoring clinical trials within oncology therapeutic areaw will be a plus;
• Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines;
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs;
• Good planning, organization and problem solving abilities;
• Ability to work with minimal supervision;
• Good communication and interpersonal skills;
• Good analytical and negotiation skills;
• Computer competency;
• Fluent in local office language and in English, both written and verbal;
• Works efficiently and effectively in a matrix environment;

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!

How to apply:

If you are interested in a Covance opportunity and would like to apply, please visit our website at covancecareers.com and look for the reference 37715BR.
You can also follow the link:

http://careers.covance.com/job-postings/37715BR/clinical-research-associates

EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us.

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