Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) is responsible for the delivery of studies at allocated sites and actively participates in the local study team(s). Collaborating closely with Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA), and other CRAs in Clinical Operations Management (COM), the Sr. CRA ensures that study commitments are achieved efficiently and on time at the country level. Acting as the main contact with the study site, the Sr. CRA monitors study conduct to ensure proper delivery and compliance. Responsibilities include selection, initiation, monitoring, and closure of assigned sites in clinical studies, adhering to Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. A Sr. CRA with demonstrated skills and experience may take on additional responsibilities as needed.

Accountabilities:
• Performing selection, initiation, interim monitoring, and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Clinical Monitoring Plan (CMP).
• Driving performance at the sites and proactively identifying and resolving study-related issues.
• Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.
• Developing recruitment plans with each site and managing enrollment to ensure sites meet enrollment milestones.
• Ensuring agreed monitoring KPIs are observed and remain within acceptable quality ranges.
• Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator.
• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements.
• In some countries, accountable for study start-up and regulatory maintenance tasks.
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.
• Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed.
• Following quality issue processes by escalating systematic or serious quality issues to relevant parties.
• Preparing for and collaborating with activities associated with audits and regulatory inspections.

Essential Skills/Experience:
• Minimum of 4 years of CRA monitoring experience
• Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification
• Excellent knowledge of international guidelines ICH-GCP, 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 knowledge of spoken and written English and Italian
• Excellent collaboration and interpersonal skills
• Good negotiation skills
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

Desirable Skills/Experience:
• Ability to work in an environment of remote collaborators and in a matrix reporting structure
• Manages change with a positive approach for self, team, and the business
• Ability to look for and champion more efficient methods/processes of delivering quality clinical trials with reduced budget and time
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
• Proactivity and assertiveness when communicating with internal stakeholders and sites
• Ability to understand the impact of technology on projects and develop computer skills while making appropriate use of systems/software in an e-enabled environment
• Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities
• Experience in all study phases and in rare medical conditions preferred

At AstraZeneca's Alexion division, we are driven by our commitment to serve patients. Our work is led by their lived experiences, driving what we do and how we do it. We know our patients by name, meet their families, and focus on their needs to tackle the toughest challenges for them. Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape with a unique R&D approach. Our entrepreneurial spirit combined with our closeness to patients brings us closer to our work and each other. Here, you will grow in a rapidly expanding portfolio, enjoy an energizing culture, and be empowered with tailored development programs designed for skill enhancement and fostering a deep understanding of our patient's journeys.

If this sounds like a team you want to be a part of, we’d love to talk!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.