Job Title:
Clinical Research Associate (CRA) Location:
United Kingdom Company:
Biotech Location:
Midlands & North-East UK About Us Our Biotech Partner is a cutting-edge respiratory biotech company focused on developing innovative therapies to transform the treatment of respiratory diseases. We are committed to improving patient outcomes through groundbreaking research and clinical development. As we continue to expand, we are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team and contribute to our mission. Job Summary The Clinical Research Associate (CRA) will be responsible for monitoring clinical trials to ensure they are conducted in compliance with regulatory standards, protocols, and company procedures. This individual will work closely with investigators, clinical sites, and the internal clinical operations team to ensure the successful execution of trials, with a particular focus on respiratory therapeutic areas. Key Responsibilities Clinical Trial Monitoring: Conduct site qualification, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) and applicable regulatory guidelines. Ensure trial sites adhere to the approved protocol, ethical guidelines, and regulatory requirements. Monitor patient recruitment, data collection, and protocol compliance at assigned sites. Site and Investigator Support: Build and maintain strong relationships with investigators and site staff to ensure smooth trial operations. Provide training to site personnel on protocol requirements, study procedures, and regulatory obligations. Serve as the primary point of contact for assigned clinical sites. Documentation and Reporting: Verify the accuracy and completeness of case report forms (CRFs) and source data. Maintain and ensure timely submission of essential documents to the Trial Master File (TMF). Prepare detailed monitoring visit reports and escalate issues as needed. Compliance and Quality Assurance: Identify and resolve site-level issues, including deviations, protocol violations, and adverse events, ensuring proper documentation and corrective actions. Support audit and inspection readiness by maintaining high-quality site files and documentation. Collaboration: Work closely with the Clinical Project Manager and cross-functional teams to meet project timelines and objectives. Contribute to the review and development of study protocols, informed consent forms, and other trial-related documents. Qualifications and Experience Education: A degree in Life Sciences, Pharmacy, Nursing, or a related field (Master’s or advanced degree is a plus). Experience: At least 1–3 years’ experience as a CRA in the pharmaceutical, biotech, or CRO industry. Hands-on experience with respiratory therapeutic areas or related indications is highly desirable. Comprehensive understanding of clinical trial processes, ICH-GCP guidelines, and UK/EU regulatory requirements. Skills: Strong organizational and time-management skills with exceptional attention to detail. Excellent written and verbal communication skills for site interactions and reporting. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Ability to travel within the UK and potentially internationally as required (up to 50%). What We Offer Competitive salary and benefits package. Opportunities for career growth within a dynamic and innovative biotech company. Flexible working arrangements, including hybrid working options. The chance to contribute to the development of life-changing therapies for respiratory patients.
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Clinical Research Associate (CRA) Location:
United Kingdom Company:
Biotech Location:
Midlands & North-East UK About Us Our Biotech Partner is a cutting-edge respiratory biotech company focused on developing innovative therapies to transform the treatment of respiratory diseases. We are committed to improving patient outcomes through groundbreaking research and clinical development. As we continue to expand, we are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team and contribute to our mission. Job Summary The Clinical Research Associate (CRA) will be responsible for monitoring clinical trials to ensure they are conducted in compliance with regulatory standards, protocols, and company procedures. This individual will work closely with investigators, clinical sites, and the internal clinical operations team to ensure the successful execution of trials, with a particular focus on respiratory therapeutic areas. Key Responsibilities Clinical Trial Monitoring: Conduct site qualification, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) and applicable regulatory guidelines. Ensure trial sites adhere to the approved protocol, ethical guidelines, and regulatory requirements. Monitor patient recruitment, data collection, and protocol compliance at assigned sites. Site and Investigator Support: Build and maintain strong relationships with investigators and site staff to ensure smooth trial operations. Provide training to site personnel on protocol requirements, study procedures, and regulatory obligations. Serve as the primary point of contact for assigned clinical sites. Documentation and Reporting: Verify the accuracy and completeness of case report forms (CRFs) and source data. Maintain and ensure timely submission of essential documents to the Trial Master File (TMF). Prepare detailed monitoring visit reports and escalate issues as needed. Compliance and Quality Assurance: Identify and resolve site-level issues, including deviations, protocol violations, and adverse events, ensuring proper documentation and corrective actions. Support audit and inspection readiness by maintaining high-quality site files and documentation. Collaboration: Work closely with the Clinical Project Manager and cross-functional teams to meet project timelines and objectives. Contribute to the review and development of study protocols, informed consent forms, and other trial-related documents. Qualifications and Experience Education: A degree in Life Sciences, Pharmacy, Nursing, or a related field (Master’s or advanced degree is a plus). Experience: At least 1–3 years’ experience as a CRA in the pharmaceutical, biotech, or CRO industry. Hands-on experience with respiratory therapeutic areas or related indications is highly desirable. Comprehensive understanding of clinical trial processes, ICH-GCP guidelines, and UK/EU regulatory requirements. Skills: Strong organizational and time-management skills with exceptional attention to detail. Excellent written and verbal communication skills for site interactions and reporting. Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS). Ability to travel within the UK and potentially internationally as required (up to 50%). What We Offer Competitive salary and benefits package. Opportunities for career growth within a dynamic and innovative biotech company. Flexible working arrangements, including hybrid working options. The chance to contribute to the development of life-changing therapies for respiratory patients.
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