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Contact Info
Karen Shiel
Life Science

+353 1 5079256
karen.shiel@lifescience.ie
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Details

Senior CRA


Reference:KS/AXIM-004751 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Our Client is an international biopharmaceutical drug discovery and development company, headquartered in South Dublin, Ireland focusing on new medicines for diseases which have a high unmet need. They develop products through a careful balance of applied pharmacology and clinical science for to enhance patient outcomes for unmet needs. They are currently seeking a Senior CRA with 3-5 years’ experience of dealing with Trials in I, II & III phases in particular. This is a full time, office-based position in South Dublin.

Role / Responsibilities:
The successful candidate will be required to support all clinical projects internationally to GCP standards. They will provide support to the Clinical team in our clients organistaion in the oversight of all the responsibilities transferred to CROs and other vendors and for delivering all tasks and projects in a timely manner within budget.
• Support the clinical team in coordinating and executing clinical projects
• They will be responsible for delivering all tasks and projects in a timely manner within budget taking a proactive approach at all times.
• They would also be expected to manage and monitor/audit both CROs and related vendors onsite.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company.
• Coordinate local and central Ethics submissions
• Provide weekly study status reports
• Prepare and review study documents
• Data analysis and reporting
• Other related clinical or regulatory support activities
• The successful candidate will be required to manage multiple clinical projects to GCP standards.
• They will provide oversight of all the responsibilities transferred by our client to CROs and other vendors.
• They will be responsible for delivering tasks and projects in a timely manner within budget taking a proactive approach at all times.
• They would also be expected to manage and monitor/audit both CROs and related vendors onsite.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company.

Education/Qualifications:
• Relevant Scientific degree with at least 4-5 years’ working in Clinical Research in a Phase I, II, III CRO and/or pharmaceutical company as a CRA.
• GCP experience in the pharmaceutical industry
• Monitoring and project management experience
• A willingness to deal with international teams working in different time zones
• Therapeutic experience and scientific knowledge in Dermatology is a distinct advantage.
• A flair for scientific writing (protocols and reports) and fully conversant with the use of EDC in clinical trials
• Excellent interpersonal, communication and problem solving skills
• Flexible in reacting to changing priorities in projects without compromising timelines and/or quality
• Ability to travel (domestic and international) as required


If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256