Lead CRA, Oncology

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee site initiation and activation efforts, encompassing site qualification, pre-trial evaluations, initiation tasks, and readiness for activation.

• Aid in the selection of countries and sites by offering local insights, feasibility assessments, and input on site evaluations.

• Develop and nurture relationships with investigator sites throughout the duration of the study.

• Act as the primary operational contact for inquiries at the site level and coordinate resolution of issues among study teams and stakeholders.

• Ensure that all necessary training, documentation, and system activities for site activation and study execution are completed.

• Propel site recruitment planning and provide enrolment assistance to meet study and country-specific objectives.

• Maintain ongoing communication with sites to track study advancement, recruitment metrics, and operational commitments.

• Evaluate site monitoring reports and facilitate compliance with informed consent documentation and any amendments.

• Supervise site deliverables, ensuring timely data entry, data examination, database lock readiness, and investigator documentation.

• Detect quality, compliance, and operational risks utilizing study data and local insights, and implement appropriate mitigation strategies.

• Support decentralized trial capabilities and assist sites in adopting study technologies and processes.

• Collaborate with internal stakeholders to enhance communication, improve site experiences, and optimize study delivery outcomes.

• Function as the main point of contact for investigative sites throughout the clinical study lifecycle, from initiation to closeout.

⛳️ Requirements

• Bachelor's degree, Registered Nurse qualification, or a comparable combination of education, training, and experience.

• Minimum of 5 years of experience in clinical research, site management, monitoring, or a related discipline.

• Proven experience in site management with prior roles as a Site Monitor/CRA.

• Demonstrated experience throughout the entire clinical trial lifecycle, from study initiation and site activation to closeout.

• Familiarity with ICH GCP, relevant regulatory requirements, and clinical trial methodologies.

• Experience utilizing clinical trial systems such as EDC, Shared Investigator Platform, Site Profile, or other similar clinical research technologies.

• Strong skills in relationship building, stakeholder management, communication, organization, and problem-solving.

• Ability to work effectively in collaboration with cross-functional and geographically diverse teams.

• Patient-centric mindset with a keen focus on quality, compliance, and operational excellence.

• Comfort in working with clinical trial systems, oversight processes, and site management tasks.

• Willingness to travel regularly throughout the UK, up to 50%.

• Proficiency in English.

• Preferred: Experience in supporting multinational clinical studies across various therapeutic areas.

• Preferred: Experience in contributing to site feasibility, recruitment planning, and optimizing study performance.

• Preferred: Knowledge of decentralized clinical trial capabilities and the related site technologies.

• Preferred: Expertise in clinical research systems, processes, or practices related to site management.

🏝️ Benefits

• Medical & Dental Insurance.

• Life Assurance.

• Pension.

• Critical Illness Insurance & Health Screenings.

• Comprehensive benefits package for eligible employees.

• Flexible work environment.

• Growth opportunities.