Clinical Research Associate II / Senior CRA – Global CRO – Italy - €competitive salary
Small medium sized division which is part of huge global CRO. Growing rapidly across all areas and are interested in speaking to Clinical Research Associates at all levels.
- Focussed on progression and growth for every employee
- Close knit team, flexible working
- Competitive salary and package
- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
- Trains site staff on the EDC system and verifies site computer system.
- Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISSC.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs by using approved IQVIA Biotech/sponsor templates and reports.
- Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Working on around 2-4 studies and managing around 15-17 sites on average.
- Must be flexible to be on site 8 days a month.
Please ensure you meet the criteria below before applying:
- Minimum of 12 months independent monitoring experience
- BS/BA/BSc (or equivalent) in one of the life sciences or health care background
- Must be able to travel domestically approximately 65%-85%.
- Valid driver’s license
What should you do next?
This Senior / Clinical Research Associate role is one not to be missed; it encompasses the opportunity to join a small close knit team within a global CRO. To discuss this role further or to find out about other clinical research jobs I’m currently working on, please get in touch or hit apply to submit your current CV.
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Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.