Senior CRA
About the role
This vacancy has now expired. Please see similar roles below...
Location: Spain, Barcelona or Madrid or home-based dependent upon experience
- Perform site feasibility and site selection in conjunction with the Study team, or independently
- Work closely with relevant departments to perform Regulatory and IEC/IRB submissions and contract negotiations
- Perform onsite and remote visits including pre-study, site initiation, interim and close out to monitor informed consent procedures, compliance protocol, GCP/ICH guidelines and other applicable regulatory requirements and assure appropriate site performance
- Provide timely and accurate visit reports as specified by project specific timelines.
- Contribute to sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings
- Maintain regular site contacts to ensure site compliance, enrolment and understanding of study requirements
- Maintain the Project Tracking System recording site visit dates, site contact notes, subject and site information
- Maintaining high quality standards, including identifying areas for improvement where applicable
- Assist with the development of departmental and project specific processes and procedures.
You will have:
- A background as a CRA, ideally within late phase studies but not essential
- Strong knowledge of ICH/GCP guidelines and/or other relevant guidelines (GEP, GPP) and local requirements (including regulatory)
- Some prior experience of study start up preferred
- Proficiency with computer/software systems
- Proven ability to manage multiple simultaneous tasks
- Fluency in written and spoken English and Spanish
- Bachelor degree or higher preferably in a scientific, medical or life sciences discipline
*LI-PW1
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