Clinical Research Associate

Clinical Research Associate (CRA I/II) – Dedicated FSP Role with Leading Pharmaceutical Sponsor….

CCS Global are working on an exclusive opportunity to join a leading global CRO who are seeking experienced and ambitious Clinical Research Associates (CRA I/II) to join a dedicated FSP team, supporting a single, prestigious pharmaceutical sponsor.

This unique opportunity offers the chance to become an integral part of the sponsor\’s clinical development operations, gaining in-depth therapeutic knowledge and contributing directly to the progression of their clinical trials portfolio.

Role Overview:

As a CRA I/II, you will be responsible for ensuring the integrity and quality of clinical data through meticulous on-site and remote monitoring activities. You will cultivate strong relationships with investigator sites, providing essential support and guidance, while adhering to ICH-GCP guidelines, sponsor SOPs, and study protocols.

Key Responsibilities:

• Conduct comprehensive monitoring visits, verifying source data against CRFs and ensuring data accuracy.
• Proactively manage site relationships, addressing queries and providing ongoing support to site personnel.
• Identify and resolve site-related issues, ensuring timely reporting of deviations and safety concerns.
• Prepare detailed monitoring visit reports and maintain accurate study documentation.
• Contribute to all stages of the clinical trial lifecycle, including site initiation, interim monitoring, and close-out.
• Ensure strict compliance with regulatory requirements and sponsor expectations.
• Participate in team meetings and training sessions.
• For CRA II, provide mentorship and training to junior CRAs, fostering their professional development.

Candidate Profile:

• Bachelor’s degree in a life science or related discipline.
• Minimum 1 year of demonstrable CRA experience (for CRA II). CRA I candidates with strong academic backgrounds will be considered for CRA I positions and 6 months of onsite monitoring as a minimum.
• Thorough understanding of ICH-GCP guidelines and relevant regulatory frameworks.
• Exceptional communication, interpersonal, and organisational skills.
• Proven ability to work autonomously and collaboratively within a team environment.
• Proficiency in Microsoft Office Suite.
• Valid driver’s license and willingness to travel as required.
• Right to work in the UK without the need for sponsorship.

Client and Opportunity Highlights:

• Exceptional Retention: This team benefits from consistently high retention rates, reflecting a supportive and positive working environment.
• Structured Progression: The client has a culture of continuous learning and development, with clear pathways for career advancement within the FSP model and the wider CRO.
• Work-Life Balance: The client prioritises employee well-being, promoting a healthy work-life balance through flexible working arrangements and supportive management.
• Dedicated FSP Role: This offers stability, project continuity and a chance to deep dive into one sponsors portfolio, rather than work across multiple studies and sponsors.
• Exposure to Cutting-Edge Clinical Trials: You will contribute to groundbreaking research within a leading pharmaceutical sponsor\’s portfolio.

To Apply:

Please submit your CV outlining your relevant experience and career aspirations to r.kelly@completeclinicalsolutions.com.

CCS Global is committed to providing equal opportunities and ensuring a fair and transparent recruitment process.