Sr. Clinical Research Associate - Zagreb
Samo za registrirane članove Zagreb, Hrvatska
prije 1 mjesec
* Ovaj raspon plaća procjena je koju je napravio beBee
Job summary
We are looking to recruit experienced Senior CRA to join our ICON FSP team and work in a sponsor dedicated role for a global biopharmaceutical company. The CRA will be responsible for site management and monitoring activities, conducting remote and onsite visits, and ensuring patient safety and ethical and regulatory compliance.Responsibilities
- Site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites
- Conducts remote and onsite visits including but not limited to initiation visits, monitoring visits, close-out visits
- Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance
- Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments
- The CRA is responsible for training the Investigator and site staff on these strict regulatory regulations and procedures
- The CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs)
- As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File
- Contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections
Your Profile
- University degree
- a minimum of 4+ years of independent on-site monitoring experience in a bio/pharma/CRO
- Proven Skills in Site Management including management of site performance and patient recruitment
- Good IT skills
- Ability to understand and analyze data/metrics and act appropriately
- Capable of managing complex issues, works in a solution-oriented manner
- Ability to travel at least 60% of the time and should possess a valid driver's license
Opis posla
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