Senior Clinical Research Associate
On-siteReading, England, United Kingdom or Manchester, England, United Kingdom
Job Summary
Conduct site monitoring visits for interventional studies, including selection, initiation, monitoring, and close-out, adhering to GCP and ICH guidelines. Adapt and track subject recruitment plans to enhance predictability while administering protocol training to sites. Evaluate site practices for protocol adherence and escalate quality issues as appropriate. Manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data query resolution. Maintain Trial Master File and Investigator's Site File documentation, submitting regular visit reports and action plans. Collaborate with the study team to support project execution. Requires 3-5 years of on-site monitoring experience and full UK right to work.
Required Qualifications
- At least 3-5 years on-site monitoring experience of interventional studies
- Degree in scientific discipline or health care or equivalent industry experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Ability to establish and maintain effective working relationships with coworkers and clients
- Full UK right to work required
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.