Investigator – Clinical Trials
Role Summary:
The Investigator leads and oversees clinical trials at their site, ensuring participant safety, regulatory compliance, and high-quality data collection. They provide medical expertise, guide study teams, and communicate effectively with sponsors, study directors, and site staff.
Key Responsibilities:
* Provide overall medical direction and review study protocols in line with GCP and investigational plans.
* Ensure participant safety, rights, and confidentiality throughout the trial.
* Oversee clinical procedures, assessments, and administration of investigational products.
* Ensure accurate, complete, and timely data collection; maintain proper documentation and regulatory compliance.
* Collaborate with clinical operations, research staff, sponsors, and IRBs, including reporting adverse events and protocol deviations.
* Review and monitor protocol adherence, study materials, and investigational product use.
* Facilitate monitoring, audits, and inspections by sponsors and regulatory authorities.
* Inform participants and IRBs appropriately if the trial is terminated or suspended.
Required Skills & Abilities:
* Strong knowledge of GCP, regulatory requirements, and biomedical research ethics.
* Excellent communication, collaboration, and critical thinking skills.
* Attention to detail and dynamic problem-solving capabilities.
* Commercial understanding of business operations.
* Willingness to travel as required (up to 10%).
Education & Experience:
* Medical degree recognised by the GMC with an active GMC license.
* GCP training and certification.
* Board certification or eligibility in a specialty relevant to the research conducted at the site.