Senior CRA I/II – UK

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

📋 Description

• Oversee and coordinate all elements of clinical monitoring and site management.

• Perform remote or on-site assessments to ensure adherence to protocols and regulatory standards, while managing documentation.

• Guarantee that trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and standard operating procedures (SOPs).

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

• Utilize risk-based monitoring, root cause analysis, and corrective/preventive actions to oversee investigator sites.

• Ensure data integrity through source data reviews, source data verification, and case report form (CRF) evaluations.

• Evaluate investigational product inventory and maintain accurate records.

• Record observations in comprehensive reports and correspondence.

• Raise deficiencies and issues to clinical management and ensure follow-up until resolution.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring responsibilities in accordance with the approved monitoring plan.

• Engage in investigator payments and attend investigator meetings.

• Provide tracking of trial status and progress updates to the Clinical Team Manager.

• Update and quality-check study systems, including the Clinical Trial Management System (CTMS).

• Identify potential investigators and initiate clinical trial sites.

• Ensure the closure of trials and the retrieval of trial materials.

• Maintain essential documentation and conduct on-site file reviews.

• Assist with project publications, tools, and additional study responsibilities.

• Facilitate communication among sites, clients, and the PPD project team.

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

• Complete expense reports and timesheets accurately.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

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

• Minimum of 2 years of experience as a clinical research monitor.

• Possession of a valid driver's license.

• Full right to work in the UK.

• Proficiency in the English language.

• Strong clinical monitoring capabilities.

• Proven understanding of medical/therapeutic areas and medical terminology.

• Excellent comprehension and demonstrated application of ICH GCPs, relevant regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and decision-making abilities.

• Competence in handling Risk Based Monitoring concepts and processes.

• Effective verbal and written communication skills.

• Customer-oriented with strong listening skills and attention to detail.

• Strong organizational and time management abilities.

• Flexibility and adaptability in various situations.

• Capability to work collaboratively in a team or independently.

• Proficient in Microsoft Office with the ability to learn necessary software.

• Good presentation skills.

🏝️ Benefits

• Competitive sign-on bonus available for qualified candidates.

• Full remote work arrangement.