Clinical Research AssociateFor our client, a company which serves global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies, we are looking for suitable candidates for the position Clinical Research Associate.
Your new role
- Performs RA and EC submissions and specializes as an expert regarding this aktivity
- Performs investigator identification and site selection and conducts pre-study visits for qualification of investigators and sites
- Prepares and facilitates site training and initiation
- Verifies clinical data against source document during routine monitoring and assist efficiently in query management process and IP accountability and reconciliation.
- Completes monitoring trip reports, reporting study progress, escalating issues related to the protocol, and ensuring patient safety and ICH/GCP compliance within EastHORN and/or Sponsor timelines and quality
- Ensures all site queries are resolved and recorded in a timely manner
- Organizes translation and provides final approval of study documents, as required
- Manages adverse event reporting and follow up
- Prepares and negotiates study budgets and contracts for the site, investigator, and study vendors and assists in obtaining contract signatures
- Prepares, organizes, and oversees site, investigator, and vendor payments − Provides feedback and support during appraisal process, performing co-monitoring visits
- Depending on experience, becomes involved (at request) in other study management areas and staff training
- Review and development (at request) of study essential documents
- Acts in Lead role on a project, assuming additional responsibilities as retailed by Line Management − Assists in business development when appropriate
- Preferably, 3 years of independent monitoring experience
- Life sciences background is required
- University Degree in Medicine is an advantage
- Experience in Regulatory Submissions / local regulations is an advantage
- Experience in all stages of clinical research (feasibility, submissions, start up, monitoring, follow up) − Experience with clinical projects with Cannabis is an advantage
- Excellent knowledge of the clinical trial process and ICH/GCP guidelines
- Experience with Electronic Data Capture is required
- Excellent organizational and time management skills to handle multiple priorities
- Leadership skills − Ability to work and to take proper decisions under presure
- Flexibility to travel
- Cost effective abilities
- Excellent written and oral communication skills in Czech and English − Social and soft skills
- Working in experienced and very professional team
- Possibility to grow within the company
- Flexible approach to work time
- Car allowance
- Competitive remuneration
- Eligibility to company bonus scheme
- 3 additional free days used as sick leave
- Place of work: Prague 4
If you are interested in this offer, please send us your structured CV. We will contact you as soon as possible.
Candidates, who are not suitable for the position, will not be contacted by
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