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Clinical Research Associate

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Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a CRA for a 12 months contract based in Basel.

The ideal candidate should have 4-5 years clinical research experience in a CRO or Pharmaceutical Company with experience in monitoring on-site clinical trials including 2+ years’ experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a).

Clinical Research Associate

Main Responsibilities:

  • Contribute to the collection and the quality control of essential documents required for the Investigational Medicinal Product (IMP) shipment approval
  • Participate in and contribute to the Clinical Pharmacology study team meetings by providing updates on monitoring activities
  • Contribute to the CRO/Site selection process
  • Perform qualification visits (when required) and initiation visits as agreed with the Clinical Pharmacologist for the assigned studies
  • Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol at the clinical sites
  • Identify CRO/Site issues, ensure resolution, and/or escalate issues if necessary
  • Report to the Clinical Pharmacology study team and the CRO/Site staff any findings noted during monitoring visits by completing monitoring visit reports and follow-up letters as per internal processes
  • Manage the assigned CRO/Site(s) through regular contacts to ensure about:
    • Site compliance with regulatory requirements and ethical standards throughout the study,
    • Adequate enrolment, and
    • Understanding of study requirements
    • Manage all study supplies, including (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
    • Supervise biological samples shipment(s) from the CRO/Site to the bioanalytical laboratory or central laboratory (when appropriate)
    • Ensure timely eCRF completion, if applicable, and proactively identify any data discrepancies by remotely reviewing the eCRF data

Qualifications and Experience:

  • University degree in science or health-related discipline and/or degree in Nursing
  • Minimum 4-5 years clinical research experience in a CRO or Pharmaceutical Company with experience in monitoring on-site clinical trials including 2+ years’ experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a), phase 1 experience advantegeous
  • Excellent oral and written communication skills in English; German language is advantageous
  • Willing and able to travel as required in different countries (up to 50%)
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Adresse

CTC Clinical Trial Consulting AG
Mr CTC Resourcing Solutions
Münchensteinerstrasse 41
4052 Basel
+41 61 695 88 66

E-Mail

Website http://www.ctcresourcing.com

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