JR CLINICAL RESEARCH ASSOCIATE
We're looking for a Junior Clinical Research Associate who will manage and monitor the conduction of clinical studies and compliance to the protocol requirements with established timelines. He/ she will be involved in all stages of the clinical study, including initiating, monitoring and closing down the study.
- Gain experience in study procedures by working with experienced clinical staff.
- Support the other CRAs (or manage entirely) during the preparation of the study documentation for the Ethics committee and/or other required Competent Authorities submissions to ensure successful outcome.
- Under close supervision, organize & perform the Site Initiation Visit: prepare and send the ISF and patients binders, train the study staff to the study-specific activities.
- Monitor the study throughout its duration, which involves both remote monitoring and on-site visits at the study sites on a regular basis.
- Verify data entered for consistency with original data source, track completed CRFs and timely respond to queries and requests.
- Liaise and communicate with study staff on conducting the trial.
- Maintain and update Clinical Master file and the essential study documentation.
- Analyze data, discuss results and prepare monitoring visit reports/clinical presentations.
- Organize and/or participate in kick-off and Investigator Meetings to review progress of ongoing clinical studies.
- Review AEs and ensure adequate communication to the NCA according to procedures.
Here a description of a good candidate:
- Academic education in Life Sciences or Medical Sciences (Biological Science, Pharmacy, Biomedical Engineering or other health-related discipline preferred)
- English fluent
- Analytical Thinking
- Effective communication
- Availability to travel (20-30%)
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