CRA - Slovakia

107698
  • Competitive
  • Slovakia, United States
  • Permanent

CRA – Slovakia

 

We are working with our client on a new Clinical Research Associate role. The client is a full-service clinical contract research organisation (CRO), who provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. They aim to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach.

 

The client leverages local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

 

This is a unique opportunity to be involved at every stage of the drug development process by providing unrivalled support to our customers. If you want an exciting career where you use your medical or health background and education, travel extensively and are instrumental in the clinical trials process, this could be the opportunity for you.

 

Job Responsibilities:

 

  • Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol.
  • Communication with the medical site staff including coordinators, clinical research physicians and their site staff.
  • Verifying adequate investigator qualifications, training, and resources, including facilities, laboratories, equipment, and staff.
  • Medical record and research source documentation review and verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements.
  • Verification that only eligible subjects are enrolled.
  • Review of regulatory documents.
  • Investigational product/drug and/or medical device accountability and inventory.
  • Verification and review of adverse events, serious adverse events, concomitant medications, and corresponding medical condition to confirm accurate data reporting in accordance with the protocol, ICH GCP and Local Regulations.
  • Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement.
  • Completion of monitoring reports and follow-up letters, which includes, but is not limited to providing summaries of the site’s status, significant findings, deviations, deficiencies, and recommended actions to secure compliance.

 

Skills Required:

 

  • Minimum of a bachelor’s degree, preferably in Health or life science related.
  • Proven CRA experience with stable career progression.
  • Fluent English & Slovak.
  • Willing to travel within Slovakia.
  • Familiarity with Microsoft® Office.
  • Strong communication and presentation skills.

 

Location: Slovakia

Permanent

Salary: flexible dependant on experience

 

Applicants are assessed on an ongoing basis. Early application is encouraged.

If interested, please get in touch by:

email: emma.carlile@peoplewithchemistry.com or call: 020 3019 5985

Emma Carlile Associate Talent Partner

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