Senior CRA II, Site Care Partner II

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

📋 Description

• Conduct site qualifications, initiate sites, monitor progress, manage sites, and perform close-out visits either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and study protocols.

• Assess the performance of sites and their personnel, offering tailored recommendations.

• Communicate or escalate critical issues while developing actionable plans.

• Verify informed consent procedures, ensure patient confidentiality, and maintain safety and clinical data integrity.

• Evaluate site processes and carry out source document reviews.

• Cross-check clinical data in case report forms against source documents and medical records.

• Address queries both remotely and on-site within established timelines.

• Utilize hardware and software for clinical study data examination and capture.

• Confirm compliance with electronic data capture standards.

• Conduct inventory, reconciliation, and reviews of storage/security for investigational products as necessary.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Document monitoring activities and maintain tracking systems.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Oversee site-level operations and communications to achieve project goals, deliverables, and timelines.

• Serve as a liaison with study site personnel, ensuring training and compliance for assigned sites and team members.

• Participate in Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings, and training sessions.

• Aid in audit readiness and follow-up actions post-audit.

• Provide oversight, training, and mentorship to junior CRAs as assigned.

• For RWLP: assist sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsors and affiliates, identify sites, enhance processes, develop informed consent forms, support regulatory updates, and engage in bid defense, RFP, budgeting, site strategy, CRF design, and edit check development.

⛳️ Requirements

• A Bachelor’s degree or RN in a relevant field, or a comparable combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Proficient computer skills with a willingness to adapt to new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Moderate critical thinking skills.

• Capability to manage travel requirements of up to 75% regularly.

• Working knowledge of relevant regulations and company SOPs/processes.

• Must be UK-based only.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when appropriate.