Experienced Senior CRA - Oncology - Phase IIb-III

Pharmaceutical Research Associates, Inc; United Kingdom; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading clinical research organization in the United Kingdom seeks an experienced Senior Clinical Research Associate to oversee site activities and manage CRAs. The role requires a minimum of 5 years of experience and a BA/BS degree, with a focus on oncology, ophthalmology, or gene therapy. Competitive salary and diverse benefits are offered, emphasizing a commitment to inclusion and equal opportunity.

Benefits

Competitive salary

Health insurance

Retirement plans

Wellness programs

Qualifications

• Minimum 5 years of experience as a Senior CRA, preferably in Oncology, Ophthalmology, or Gene Therapy.
• Strong knowledge of GCP regulations and software.
• Willingness to travel up to 40%.

Responsibilities

• Serve as Lead CRA for specific studies, providing oversight and support.
• Drive activities during site initiation, monitoring, management, and close-out.
• Ensure site staff are trained and maintain compliance with protocols.

Skills

Site monitoring

Management expertise

Communication skills

Knowledge of GCP

Education

BA/BS degree

Job description

Overview

As an experienced Senior Clinical Research Associate, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities

• Serve as Lead CRA for specific studies, providing oversight and support to assigned CRAs.
• Share study-level information with CRAs and establish site monitoring strategies.
• Drive activities during site initiation, monitoring (including remote), management, and close-out, following SOPs, WIs, and policies.
• Implement risk-based monitoring approaches and work with sites to resolve issues promptly.
• Ensure site staff are trained, with complete and accurate training records throughout all trial phases.
• Collaborate with the study team during site activation to expedite processes.
• Maintain site compliance with protocols, ICH-GCP, and regulations.
• Assess site facilities and staff adequacy for trial conduct.
• Verify source data and documentation meet ALCOA-CCEA standards.
• Participate in recruitment strategies and ensure adequate supplies and proper handling of clinical drugs and IMPs.
• Oversee data entry, query resolution, and data integrity.
• Report AEs/SAEs within timelines and document appropriately.
• Maintain trial documentation and prepare for close-out activities.
• Develop therapeutic knowledge and act as local protocol expert.
• Coordinate with CTM on CAPA for QA audits and site issues.
• Build relationships with stakeholders, investigators, and site staff.
• Assist with regulatory submissions as needed.
• Manage up to 10 sites across 2-4 protocols, managing travel within guidelines.

Qualifications

Minimum 5 years of experience as a Senior CRA, with site monitoring and management expertise, preferably in Oncology, Ophthalmology, or Gene Therapy. BA/BS degree required. Strong knowledge of GCP, regulations, and software. Willing to travel up to 40%. Proficient in English. Excellent communication skills.

What ICON offers: Competitive salary, diverse benefits including health insurance, retirement plans, wellness programs, and more. Committed to inclusion and equal opportunity. For accommodations, contact us via the provided link.