The CRA oversees the progress of Clinical Trials, ensuring that they are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), the applicable Regulatory requirements. A CRA may be working on more than one trial for more than one client at any given time.
- Client Liaison
- Clinical service provision
- Day to day organisation and management of study tasks
- Preparation of Regulatory and EC submissions
- Monitoring in accordance with contract, regulations & SOPs
- Site monitoring and Management
- SAE Reporting
- Reporting status and updates to clients.
- Attendance at management meetings.
- Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
- Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, Nursing or a relevant life sciences discipline;
- IMPORTANTLY: At least 2-3 years of independent monitoring experience;
- Work experience within either a Contract Research Organisation or Pharmaceutical company;
- A clear understanding of the drug development process;
- Significant experience in performing a Clinical Research Associate role;
- Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials;
- Ability to independently perform pre-study initiation, interim monitoring and close out visits as required;
- Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines;
- Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail;
- Fluency in English.
May suit experienced person seeking to return to work.
Work Schedule: Part-time (1-2 days per week).
Location: Virtual Home Office with occasional travel to our office in Dublin.
Travel Requirements: Ability to travel occasionally for meetings in the UK.
How to Apply?
Clinical Trial EndPoint Ltd was established in 2002 by two former senior executives from the pharmaceutical sector. Stephen Dorman was formerly managing director of world leading pharma company GSK (Ireland) and Tomas O’Mahoney was European Clinical Project Manager in Sanofi. CTEP has its offices and development centre at City West, Dublin 24.
The company specialises in providing electronic patient data capture (EDC) software for real-world (observational) studies to the pharmaceutical sector either directly or through global Contract Research Organisations (CROs).
The demand for real-world patient data is growing rapidly and there is clear recognition that the software functionality in post-approval studies should be different to that deployed in pre-approval clinical trials. CTEP’s RealWorld EDC product has been developed specifically to capitalize on this opportunity. From a strong customer base in Ireland, CTEP is now working to intensify its sales and marketing activities within Europe and key global markets such as Japan.
Japan is a niche market for RealWorld EDC as Post Marketing Surveillance studies are mandatory in this large market. CTEP has been localising its software specifically for the Japanese market. Progressing sales and marketing activities in Japan will be a key area of focus in this role.
NOTE: No third party or agencies required. Local agency relationships in place. Direct applicant's need only apply to this advert.