Remote CRA II – Start-Up & Maintenance

Kapadi; Remote; GBP 40,000 - 55,000; Full time

Job summary

A leading clinical research organization is seeking a motivated Clinical Research Associate II - Study Start-Up and Maintenance in the UK. This homebased position involves performing regulatory document maintenance for clinical research projects, liaising between sites and project teams, and mentoring junior team members. Ideal candidates should possess a Bachelor's Degree in Life Sciences and a minimum of 3 years of relevant experience in clinical research, with strong knowledge of ICH guidelines and regulatory requirements.

Qualifications

• Minimum of 3 years of experience in clinical R&D in pharmaceutical, biotechnology or CRO.
• 5+ years of experience in a study start-up position.
• Strong knowledge of ICH guidelines and regulatory requirements.

Responsibilities

• Perform study startup and regulatory document maintenance for clinical projects.
• Serve as the primary liaison between site and project team throughout the study lifecycle.
• Manage Central IRB submissions and local CTIS submissions for Europe.

Skills

Clinical research knowledge

Regulatory compliance

Project management

Education

Bachelor’s Degree in Life Sciences, Medicine, Pharmacy, or Nursing

Job description

A leading clinical research organization is seeking a motivated Clinical Research Associate II - Study Start-Up and Maintenance in the UK. This homebased position involves performing regulatory document maintenance for clinical research projects, liaising between sites and project teams, and mentoring junior team members. Ideal candidates should possess a Bachelor's Degree in Life Sciences and a minimum of 3 years of relevant experience in clinical research, with strong knowledge of ICH guidelines and regulatory requirements.