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Clinical Research Associates I
Labcorp
Place of work
Prague
Prague
Contract type
full-time
full-time
Information about the position
Job description, responsibilities and duties
At the moment we are looking forward to hire up to three Clinical Research Associates I to join our growing operations in Prague. 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. If you have at least 1 years of experience in monitoring clinical trials, we want to talk to you about this opportunity.
Responsibilities:
• Site administrating and site monitoring responsibility for clinical studies according to Covance 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 Covance 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 and SCRAs).
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs).
Responsibilities:
• Site administrating and site monitoring responsibility for clinical studies according to Covance 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 Covance 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 and SCRAs).
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs).
Employee perks, benefits
We Offer:
Covance's ongoing success offers team members unsurpassed growth and career development opportunities at 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!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities at 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!
Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Information about the selection process
To apply please visit our career site quoting the position name and the appropriate reference number - 37715BR.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Personality requirements and skills
Required education, skills and experience:
• 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 Czech and English language.
• Understanding of the clinical trial process;
• Minimum 1 year of relevant clinical research experience in pharmaceutical or CRO industries.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
• 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 Czech and English language.
• Understanding of the clinical trial process;
• Minimum 1 year of relevant clinical research experience in pharmaceutical or CRO industries.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
Advertiser
Brief description of the company
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ID: 1715626
Datum zveřejnění: 16.4.2014
2014-04-16
lokalita: Prague Pozice: Agricultural Engineer, Agronomist, Clinical Research Associate Společnost: Labcorp