Clinical Research Associate - Midlands

Location: Midlands

Travel: Approximately 65–75% (about 2–3 days per week, domestic and international)

Role Overview

We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements. You will take ownership of allocated sites, actively expand our clinical research territory by identifying and developing new sites, and contribute as a subject matter expert on monitoring processes and systems across internal workstreams.

Key Responsibilities

• Build and sustain strong relationships with investigative sites across all trial phases.
• Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents.
• Develop deep understanding of study protocols and procedures.
• Coordinate cross-functional tasks to achieve Site Ready status.
• Participate in site selection and validation; provide informed input to decisions.
• Conduct remote and on-site monitoring to ensure:

• Data integrity (complete, accurate, unbiased).
• Protection of subjects’ rights, safety, and well-being.

Travel Requirements

Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week). Valid driver’s license preferred; required in certain countries.

Qualifications, Skills, and Experience

• Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively.
• Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks.
• Demonstrated mentoring and leadership capability.
• Hands-on knowledge of Good Documentation Practices.
• Proven site management expertise, including independent oversight of site performance and patient recruitment.
• High-level monitoring skills with sound, independent professional judgment.
• Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools.
• Ability to interpret data/metrics and take appropriate action, including in virtual settings.
• Experience conducting site motivation visits to boost enrollment.
• Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions.
• Ability to mentor junior CRAs and perform co-monitoring visits.

Required Skills: Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Good Clinical Practice (GCP), Medical Research, Protocol Adherence, Regulatory Compliance.

Behavioral Competencies

• Excellent time management, organization, interpersonal skills, conflict management, and problem solving.
• High independence across multiple protocols, sites, and therapy areas.
• Strong sense of accountability and urgency; able to prioritize and multitask in changing environments.
• Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships.
• Customer-focused mindset with high standards of quality and compliance.
• Positive, growth-oriented, self-driven, and professional demeanor aligned with company values.

Education and Experience

Bachelor’s degree (or higher) with extensive direct site management (monitoring) experience in bio/pharma/CRO.

What We Offer

• Opportunity to shape clinical research at high-performing sites and contribute to global development programs.
• A collaborative environment with growth, mentorship, and continuous improvement.
• Competitive compensation and benefits.