Our client is looking for a Clinical Research Associate to join an energetic company for a one year contract. The main focus of the role will be to support the early phase group by carrying out and conducting monitoring visits.
- Conduct visits to clinical study sites from qualification and initiation to closeout
- Monitor the studies to ensure quality and accuracy of data against source documents
- Responsible for monitoring studies against defined milestones and timelines to assure that all deliverables are met as described in the Monitoring Plan
- Maintain eTMF for all clinical sites and perform eTMF reconciliation
- Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks
- Assist in improving and maintaining SOPs
- Able to help the site navigate informed consent issues and support IRB approval process
- Bachelor's degree preferred
- Ability to travel up to 50%
- At least 5 years of previous monitoring experience preferred
- Knowledge and understanding of clinical research regulatory requirements i.e. GCP and ICH guidelines
- Proven written and verbal skills
- Demonstrated ability to go above and beyond what is asked of them
Sthree US is acting as an Employment Business in relation to this vacancy.