Clinical Research Associate – Multi-Sponsor

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

📋 Description

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

• Assess the performance of site and site staff, providing recommendations for site-specific actions.

• Communicate serious issues to the project team, escalating as necessary, and develop action plans.

• Verify the informed consent processes and associated documentation.

• Evaluate subject/patient safety, integrity of clinical data, protocol deviations/violations, and pharmacovigilance matters.

• Review site processes and examine source documents and medical records.

• Confirm that clinical data entered in case report forms is both accurate and complete.

• Address queries both remotely and on-site, guiding site staff toward resolution.

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

• Ensure compliance with electronic data capture standards.

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

• Verify the dispensing and administration of investigational products in accordance with the protocol.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document activities through letters, trip reports, communication logs, and other project-related documents.

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

• Monitor observations, track ongoing status, and resolve action items.

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

• Serve as the primary liaison with study site personnel or collaborate with the Central Monitoring Associate.

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

• Prepare for and participate in Investigator Meetings and sponsor face-to-face meetings.

• Engage in global clinical monitoring/project staff meetings and clinical training sessions.

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

⛳️ Requirements

• 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 and a willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Capacity to manage travel requirements of up to 75% on a regular basis.

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

• Ability to adhere to clinical protocols, regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP).

• Willingness to complete assigned training as required.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• A culture of inclusivity.

• Reasonable accommodations, when appropriate, to help employees or applicants perform essential job functions.