My client, a large research based Biopharmaceutical company, currently seek a number of CRA / Senior CRA?s to join their team on an initial 12 month contract basis. Within these roles you will be responsible for anticipating and proactively solving study related clinical site issues, from study start up through to close out of studies.
100% homebased working is possible, and you can be based across the UK.
- Good Clinical Practices (GCPs), ICH Guidelines, client Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
- Monitor activities conducted by clinical investigative sites as they relate to the clients clinical studies to ensure successful execution of the protocol.
- Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 14 studies in accordance with applicable regulations, Good Clinical Practices (GCPs) and ICH Guidelines.
- Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Manage investigator payments as per executed contract obligations. Negotiate investigator / hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
- Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis.
- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing)
- 1+ years of clinical research monitoring
- Strong ICH/GCP guideline experience
- Ability to address study related clinical site issues with appropriate guidance
- Demonstrated business ethics and
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: BH-25670
Website: Achieva Group Limited
- Posted: 18th May 2021
- Expires: 15th June 2021