Clinical Research Associate - Midlands

Clinical Research Associate

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

About Our Company

Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements.

We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core.

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, 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 timely documentation of visits and non‑visit reports.
• Collect, review, and monitor regulatory documentation for start‑up, maintenance, and close‑out.
• Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance.
• Identify, assess, and resolve site performance, quality, or compliance issues; engage escalation pathways as required.
• Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities).
• Maintain accurate, timely documentation in CTMS, e TMF, and other systems.
• Share best practices, drive continuous improvement, and deliver training as a process SME.
• Support and/or lead audit/inspection activities.
• Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities.
• Mentor and buddy junior CRAs; conduct co‑monitoring and quality control visits where appropriate.

Qualifications, Skills, and Experience

• Fluent in English, with strong written and verbal communication skills.
• Robust knowledge of clinical research, trial phases, ICH/GCP, and local regulations.
• 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).
• 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 prevention/corrective actions.
• 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.
• #J-18808-Ljbffr