Clinician – CRA

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

📋 Description

• Carry out and coordinate activities related to clinical monitoring and site management.

• Perform remote or on-site visits to evaluate compliance with protocols and regulations, as well as manage necessary documentation.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigative sites.

• Monitor investigator sites employing a risk-based monitoring strategy.

• Utilize root cause analysis, critical thinking, and problem-solving skills to identify failures in site processes and propose corrective/preventive actions.

• Ensure the accuracy of data through source document reviews, source data verification, and case report form assessments.

• Evaluate the inventory and records of investigational products.

• Record observations in reports and correspondence, escalating deficiencies and issues to clinical management.

• Keep in touch with investigative sites between monitoring visits to verify adherence to protocols, resolve issues, and ensure timely data entry.

• Carry out monitoring activities as outlined in the approved monitoring plan.

• Participate in investigator payments and meetings.

• Assist in identifying potential investigators and initiating clinical trial sites per relevant procedures.

• Conduct trial close-out activities and retrieve trial materials.

• Ensure that essential documents are complete and in accordance with ICH-GCP and relevant regulations.

• Carry out on-site file reviews as specified by the project.

• Provide updates on trial status and progress.

• Maintain comprehensive and accurate clinical trial systems.

• Facilitate communication among investigative sites, the client company, and internal project teams.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete administrative duties such as expense reports and timesheets.

• Assist with project publications/tools and contribute to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification, or an equivalent relevant academic/vocational qualification.

• A minimum of 3 years of extensive clinical experience in a healthcare setting applicable to clinical research.

• Capability to work autonomously or collaboratively within a team.

• Strong organizational skills and meticulous attention to detail.

• Demonstrated ability to efficiently and effectively manage multiple tasks.

• Proficiency in analyzing project-specific data and systems for accuracy and efficiency.

• Strong customer service orientation.

• Adaptability to reprioritize workload in response to shifting project timelines.

• Ability to acquire and maintain up-to-date knowledge of ICH GCPs, applicable regulations, and procedural documentation.

• Proficiency in English and local languages.

• Competent computer skills, particularly in MS Office, including Word, Excel, and PowerPoint.

• Capability to learn and master clinical trial database systems.

• Self-driven with a positive demeanor and strong interpersonal skills.

🏝️ Benefits

• Resources available to help achieve personal career objectives.

• Accessibility services and reasonable accommodations for job seekers with disabilities.

• Equal employment opportunities and a commitment to non-discrimination.