Senior Clinical Research Associate, UK Monitoring Experience

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management, and close-out visits, either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol compliance.

• Assess the performance of sites and site staff, providing recommendations and action plans.

• Confirm informed consent processes, maintain subject/patient confidentiality, and ensure the integrity of safety and clinical data.

• Evaluate site processes and carry out source document and medical record reviews.

• Validate clinical data entered into case report forms and address queries within set timelines.

• Utilize hardware and software tools for clinical study data review and capture.

• Ensure compliance with electronic data capture standards.

• Manage investigational product inventory, including reconciliation, storage, dispensing, and administration checks, as needed.

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

• Record monitoring activities through letters, trip reports, communication logs, and project documents.

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

• Monitor observations, statuses, and action items to ensure resolution.

• Oversee site-level activities and communications to achieve project objectives, deliverables, and timelines.

• Collaborate with project site personnel and Central Monitoring Associates.

• Ensure training and compliance for assigned sites and project-specific site team members.

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

• Aid in audit readiness, preparation, and follow-up actions.

• Provide training or mentorship to junior CRAs and conduct training/sign-off visits as assigned.

• For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, create country-level informed consent forms, identify operational efficiencies, participate in bid defense meetings, and collaborate with sponsors, affiliates, regulatory teams, medical science liaisons, and local country personnel.

⛳️ Requirements

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

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

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal skills.

• Basic critical thinking abilities.

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

• Experience in UK monitoring.

• Working understanding of ICH/GCP Guidelines, Good Pharmacoepidemiology Practice (GPP), relevant regulations, and company SOPs/processes.

• Competence in conducting clinical monitoring activities on-site or remotely.

• Skill in managing site-level activities, communications, and project objectives, deliverables, and timelines.

• Ability to swiftly adapt to changing priorities.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate, to assist employees or applicants with disabilities.