The Senior Clinical Research Associate (CRA) has local responsibility for the delivery of studies at their assigned sites and actively participates in local study teams. The CRA collaborates with team members including Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA), and other CRAs to ensure timely and efficient study commitments at the site level. The CRA serves as the primary contact with the study site and monitors study conduct to ensure compliance and delivery.
The CRA is responsible for the identification, selection, initiation, monitoring, and closure of sites in clinical studies, ensuring adherence to Alexion Procedural Documents, ICH-GCP guidelines, and local regulations. They ensure that site deliverables meet study commitments.
Experienced CRAs may undertake additional responsibilities, such as Lead CRA roles.
Accountabilities
- Review and track regulatory and relevant documents.
- Maintain document production, ensuring compliance with templates and versions.
- Manage clinical-regulatory documents in the Global Electronic Library (GEL) per the Global Document List (GDL) and AstraZeneca guidelines.
- Handle electronic submissions according to technical standards like Submission Ready Standards (SRS).
- Lead administrative aspects for the CSR.
- Contribute to non-drug project work, including training and procedure development.
- Maintain information in AstraZeneca tracking tools and support their use.
- Track study materials and equipment.
- Manage administrative tasks during the study, audits, and inspections.
- Coordinate and prepare for meetings, liaising with participants and vendors.
- Prepare and distribute meeting materials and communications.
- Foster a culture of leadership, creativity, and collaboration.
Qualifications
- Minimum 3 years of CRA monitoring experience.
- Bachelor's degree in life sciences or equivalent.
- Strong knowledge of ICH-GCP, GMP/GDP, and local regulations.
- Good medical knowledge and understanding of drug development and clinical study management.
- Excellent attention to detail, communication, collaboration, and negotiation skills.
- Willingness to travel up to 70%.
Preferred Skills
- Experience working remotely and in matrix organizations.
- Ability to manage change and prioritize tasks effectively.
- Proactive communication and technological proficiency.
- Experience across all study phases, especially in rare diseases.
About Alexion Canada
Since 2009, Alexion has been dedicated to bringing innovative medicines to Canadians with rare diseases. Our team of over 200 employees includes research, development, and local clinical trial professionals committed to patient impact. We foster a diverse, inclusive environment and are committed to equal opportunity employment.
