Clinical Research Associate Jobs

About The Position

Requirements

• Minimum of 4 years of CRA monitoring experience.
• Bachelor’s degree in a related discipline, preferably life science, or equivalent qualification.
• Excellent knowledge of ICH-GCP international guidelines and basic knowledge of GMP/GDP.
• Excellent knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant Alexion therapeutic areas.
• Good understanding of the drug development process.
• Excellent understanding of clinical study management, including monitoring, study drug handling, and data management.
• Excellent attention to detail.
• Excellent written and verbal communication skills.
• Excellent collaboration and interpersonal skills.
• Good negotiation skills.
• Flexibility in schedule and willingness to travel; travel may be as high as 70% during busy periods.
• Valid driving license.

Nice To Haves

• Ability to work with remote collaborators and in a matrix reporting structure.
• Positive approach to managing change for self, the team, and the business; views change as an opportunity to improve performance and add business value.
• Ability to identify and champion more efficient and effective methods or processes for delivering quality clinical trials with reduced budgets and timelines.
• Ability to prioritize and manage multiple tasks with conflicting deadlines.
• Proactivity and assertiveness when communicating with internal stakeholders and sites.
• Ability to understand technology’s impact on projects and use and develop computer skills appropriately in an e-enabled environment.
• Team-oriented and flexible, with the ability to respond quickly to shifting demands and opportunities.
• Experience across all study phases and in rare medical conditions.

Responsibilities

• Perform site selection, initiation, interim monitoring, and closeout visits remotely and onsite, as well as remote data checks, in accordance with the study-specific Clinical Monitoring Plan timelines.
• Drive site performance; proactively identify and ensure timely resolution of study-related issues, escalating them as appropriate.
• Train, support, and advise investigators and site staff on study matters, including Risk Based Quality Management (RBQM) principles.
• Develop recruitment plans with each site and manage and support enrollment to meet site and study milestones; document recruitment barriers and mitigation plans.
• Ensure agreed monitoring KPIs remain within acceptable quality ranges, including action-item aging, SDV metrics, data-entry metrics, query aging, and monitoring-visit report metrics.
• Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the Principal Investigator, including follow-up letters, in line with required timelines and Alexion SOPs.
• Ensure timely collection and uploading of essential documents to the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements; support or participate in regular eTMF QC checks.
• Where required, support study start-up and regulatory maintenance, including collecting, preparing, reviewing, and tracking application documents and submitting appropriate documents to EC/IRB and Regulatory Authorities.
• Contribute to nomination and selection of potential investigators and assist with feasibility activities.
• Collaborate with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed.
• Escalate systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues to PMCO, Director COM, HCO, and/or the Quality Group as required.
• Prepare for and collaborate on audits and regulatory inspections in liaison with PMCO, Director COM, and the Quality Group.
• Take on additional responsibilities and tasks as needed, potentially including Lead CRA responsibilities.