Clinical Research Associate II / Senior CRA - Home-Based UK
- Contract Type
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review
- Investigational product/drug accountability and inventory
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Minimum of a bachelor’s degree; Health or life science related field preferred
- 2-4 years of proven CRA experience
- Willing to travel approximately 60-80% nationally
- Familiarity with Microsoft® Office
- Strong communication and presentation skills a plus
This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.
To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.
Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.
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