Senior Clinical Research Associate (Alexion)

Senior Clinical Research Associate
Region: North of England

Competitive salary & Benefit package

The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the UK country team. The Sr. CRA works closely with other CRAs and the UK Country Operations Management (COM) Team to ensure that study commitments are achieved efficiently and on time. Acting as the main contact with the study site, the Sr. CRA is responsible for monitoring study conduct to ensure proper delivery and compliance. This role involves the 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 and tasks as needed, such as Lead CRA. The position is field-based and requires national coverage, with the ideal candidate residing in the North region.

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).
• Advancing performance at the sites by proactively identifying and ensuring timely resolution of study-related issues and raising them as appropriate.
• 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 and studies achieve desired outcomes. Documenting recruitment barriers and mitigation plans.
• Track essential data to ensure quality levels are maintained, such as aging of Action Items, SDV statistics, query age, and MV reports statistics.
• Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with Alexion SOPs.
• Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements. Supporting/participating in regular QC checks of the eTMF.
• CRAs are accountable for supporting study start-up activities. Tasks may include collection, preparation, review, and tracking of documents for the application process.
• Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.
• Collaborating with local Medical Affairs and other internal collaborators as needed.
• Advancing quality issue processes by raising detailed or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO, and/or Quality Group as required.
• Preparing for and collaborating with activities associated with audits and regulatory inspections in liaison with SML and Quality Group.

Essential Skills/Experience:

• Minimum of 4 years of CRA monitoring experience
• Bachelor's degree in a related field, preferably in life science, or equivalent experience
• 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 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)
• Valid driving license

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. Sees change as an opportunity to improve performance and add customer value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
• Being proactive and assertive in communication with internal collaborators and sites
• Ability to understand the impact of technology on projects and to use 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 embrace an opportunity where work isn’t ordinary. Our closeness to patients brings us closer to our work and each other. With a rapidly expanding portfolio, we foster an energizing culture where people build connections to explore new ideas that profoundly impact patients' lives. We value diversity, inclusion, integrity, innovation, and connection to patients' lived experiences. Here, your career is not just a path but a journey to making a difference where it truly counts.

Ready to make a difference? Apply now!

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.