Clinical Specialist/Junior Clinical Research Associate

Thomson Reuters; City of Westminster; On-site; GBP 30,000 - 45,000; Full time

Job summary

A global leading Biotech company is seeking a Clinical Specialist/Junior Clinical Research Associate to manage site operations, conduct evaluations, and ensure compliance with ICH-GCP guidelines. The ideal candidate holds a graduate degree in a relevant field and has a minimum of 2 years of CRA experience. This role requires strong communication skills and an understanding of clinical trial management processes. Interested applicants should contact via the provided email for further information.

Qualifications

• Minimum of 2 years of proven experience as a Clinical Research Associate (CRA).
• Postgraduate qualifications are considered an advantage.
• Strong working knowledge of ICH-GCP guidelines.

Responsibilities

• Conduct site evaluation and setup for SCENESSE® commercial distribution.
• Maintain communication with sites involved in SCENESSE® distribution and clinical trials.
• Monitor data collection and pharmacovigilance/safety reporting.

Skills

Clinical trial management

ICH-GCP guidelines knowledge

Biological Sciences knowledge

Communication

Education

Graduate degree in Biological Sciences, Nursing, Pharmacy, or related discipline

Job description

Overview

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process? Our Client, a global leading Biotech company is looking for a Clinical Specialist/Junior Clinical Research Associate.

Tasks

• Conduct site evaluation and setup for SCENESSE® commercial distribution, including dosing training in collaboration with the Clinical Project Manager or designee.
• Maintain communication with sites involved in SCENESSE® commercial distribution and potential clinical trial sites.
• Collect essential documents in compliance with ICH‑GCP E6 (R2) and applicable regulations.
• Monitor data collection and pharmacovigilance/safety reporting at post‑authorisation study sites.
• Manage site setup, initiation, monitoring, and close‑out for clinical and post‑authorisation studies as needed.
• Oversee site operations including supply management and payment processes.
• Track study and clinical trial status and provide progress updates to the team.
• Prepare and submit documentation to EC/IRB and regulatory authorities.
• Participate in investigator meetings and relevant conferences.
• Contribute to newsletters and other communications as directed by the Clinical Project Manager or designee.
• Assist with audits as required.
• Support process improvement initiatives and contribute to workflow enhancements.
• Conduct literature reviews to support clinical and regulatory activities.

Profile

• Hold a graduate degree in Biological Sciences, Nursing, Pharmacy, or a related discipline.
• Postgraduate qualifications are considered an advantage.
• Minimum of 2 years of proven experience as a Clinical Research Associate (CRA).
• Strong working knowledge of ICH‑GCP guidelines.
• Demonstrated experience in managing clinical trials and projects.

Please contact me on [e-mail] or please call me on [phone] for further information.