Clinical Research Director
hace 5 días
Job Summary
As a Principal CRA at ICON, you will be responsible for managing clinical trials and ensuring the accuracy and completeness of data entered into systems.
You will be working with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives.
Key Responsibilities
- Maintain timelines and ensure accuracy and completeness of data entered into systems.
- Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
- Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by the respective project manager.
- Help successfully implement study plans for specific phases of a trial.
- Slot into existing projects in order to identify potential problems and improve timelines.
- Co-ordinate and advise others on all the necessary activities required to set up and monitor a study, including:
- Identify investigators.
- Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
- Placement, pre-study and initiation visits.
- Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate.
- Complete accurate study status reports.
- Deal with sponsor generated queries in a timely manner.
- Ensure the satisfactory close-out of investigator sites.
- Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
- Ensure correct archiving of files on completion of a study.
- Assume additional responsibilities as directed by the Project Manager.
- Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
- Co-ordinate and/or participate in feasibility studies for new proposals, as required.
Requirements
- Bachelor's degree in a health, life sciences or other relevant field of study.
- Minimum 8 years' work experience of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
- Availability to travel is required.
- All employees must read, write and speak fluent English and host country language.
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