Sr. CRA 1 - Single Sponsor Dedicated
On-siteReading, England, United Kingdom
Job Summary
Conduct site monitoring visits, including selection, initiation, and close-out, ensuring sites adhere to the study protocol, Good Clinical Practice, and regulatory guidelines. Drive subject recruitment plans, track enrollment progress, and manage data queries while evaluating site practices and escalating quality issues. Administer protocol training, maintain Trial Master Files and Investigator's Site Files, and generate regular visit reports and follow-up documentation. Collaborate with study teams to support project execution, manage regulatory submissions, and handle site financial management as required. This role is based in Reading, UK, and requires at least two years of on-site monitoring experience.
Required Qualifications
- Bachelor's Degree Degree in scientific discipline or health care
- at least 2 years of on-site monitoring experience
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements
- Good Clinical Practice (GCP)
- International Conference on Harmonization (ICH) guidelines
- proficiency in use of Microsoft Word, Excel and PowerPoint
- use of a laptop computer and iPhone and iPad
- Written and verbal communication skills
- good command of English language
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Desired Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred
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