Job Description

Overview

I am seeking a professional and experienced Clinical Research Associate to join the team in the UK or 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

1. Oversee regulatory compliance for clinical trials in accordance with local and international regulations
2. Coordinate with regulatory authorities and ethics committees for approvals and submissions
3. Ensure documentation and reporting are in line with regulatory requirements
4. Conduct site visits to assess regulatory compliance and provide support and guidance to site staff
5. Collaborate with cross-functional teams to ensure regulatory milestones are achieved

Qualifications

1. Bachelor's degree in a scientific or healthcare discipline
2. Proven experience as a Clinical Research Associate in regulatory activities
3. In-depth knowledge of regulatory requirements for clinical trials in the UK
4. Strong understanding of ICH-GCP guidelines and other relevant regulations
5. Excellent communication and interpersonal skills
6. 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

1. Opportunity to work on a part-time basis with a flexible schedule
2. Gain valuable experience in regulatory activities within clinical research
3. Collaborate with a dynamic and supportive team
4. Competitive compensation package

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