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Clinical Research Coordinator
1 month ago
Capilaux is seeking a highly skilled Clinical Research Coordinator to oversee the progress of clinical and application research trials. As a key member of our Clinical and Application Research Team, you will play a critical role in advancing our cutting-edge clinical trials and ensuring the highest standards of quality and compliance.
Key Responsibilities:
- Ensure compliance with regulatory standards and protocols.
- Prepare and manage essential study documentation.
- Verify accurate patient data recording.
- Conduct on-site training and provide motivation and guidance to investigators.
- Monitor adherence to protocols, GCP, and internal SOPs.
- Perform routine site visits and assessments.
- Complete detailed audits and verify activities at investigative sites.
- Procure, store, and disseminate study supplies.
- Mentor and train new department personnel.
- Bridge the gap between Principal Investigators and research personnel.
Key Objectives/KPIs:
- Inspire and motivate the research team to achieve project targets.
- Conduct QA/QC of investigator activities.
- Ensure research staff meet targets and deliverables within set timelines.
- Perform trend analysis and audits to enhance trial execution.
- Take ownership of all study monitoring duties.
- Identify and develop new training materials, SOPs, and documentation as necessary.
Required Skills, Experience, and Attributes:
- Degree in a scientific subject.
- Proven clinical trial experience in a research setting.
- Experience with Phase I-IV trials, with a preference for Phase II-III.
- Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, ICH-GCP, GDPR, and Research Governance Framework Legislation.
- Strong ability to manage multiple priorities effectively.
- Excellent interpersonal skills.
- Ability to communicate clearly and resolve conflicts collaboratively.
- Operates with a high level of due diligence.
- Strong initiative and problem-solving skills.
