Overview I am seeking a professional and experienced Clinical Research Associate to join the team in Spain for a respected Sponsor company I am partnered with. This is a freelance, part-time position with a 0.5 FTE commitment for a 12-month duration. The successful candidate will be responsible for regulatory activities related to clinical trials.
Responsibilities Oversee regulatory compliance for clinical trials in accordance with local and international regulations
Coordinate with regulatory authorities and ethics committees for approvals and submissions
Ensure documentation and reporting are in line with regulatory requirements
Conduct site visits to assess regulatory compliance and provide support and guidance to site staff
Collaborate with cross-functional teams to ensure regulatory milestones are achieved
Qualifications Bachelor's degree in a scientific or healthcare discipline
Proven experience as a Clinical Research Associate in regulatory activities
In-depth knowledge of regulatory requirements for clinical trials in Spain
Strong understanding of ICH-GCP guidelines and other relevant regulations
Excellent communication and interpersonal skills
Ability to work independently and manage time effectively
Day-to-Day As a Clinical Research Associate, you will be responsible for ensuring regulatory compliance throughout the lifecycle of clinical trials. This will involve liaising with regulatory authorities, conducting site visits, and maintaining accurate documentation to support regulatory submissions.
Benefits Opportunity to work on a part-time basis with a flexible schedule
Gain valuable experience in regulatory activities within clinical research
Collaborate with a dynamic and supportive team
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