The Senior Clinical Research Associate (CRA) has local responsibility for the delivery of studies at their assigned sites and is an active participant in the local study team(s). The CRA works closely with local team members, including Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA), and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner on a site level. The CRA acts as the main contact with the study site and is responsible for monitoring the study conduct to ensure delivery and compliance.

The CRA is responsible for the identification, selection, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. The CRA ensures that the sites deliver according to their respective commitments in the individual studies.

A CRA with demonstrated abilities and experience may take on additional study-level responsibilities and tasks as needed (e.g., Lead CRA).

Accountabilities

• Collects, reviews, and tracks regulatory and other relevant documents
• Initiates and maintains production of documents, ensuring template and version compliance
• Creates and / or imports clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL), ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL
• Supplies electronic applications / submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
• Leads administrative appendices for the CSR
• Provides input into non-drug project work including training activities and development of procedures as needed
• Monitors the set-up and maintenance of information in AstraZeneca tracking and communication tools (e.g., IMPACT, Clinical Partners Portal, and eRoom) and supports others in the usage of these systems
• Manages and coordinates tracking of study materials and equipment
• Monitors administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs
• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, monitor meetings, Investigator meetings. Liaises with internal and external participants and / or vendors
• Prepares, contributes to, and distributes presentation material for meetings, newsletters, and websites
• Has personal responsibility for creating a culture of courageous leadership, creativity, and collaboration

You will need to have :

Minimum of 3 years of CRA monitoring experience

Bachelor’s degree in related field, 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 details.

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)

Solid knowledge of clinical development processes with strong emphasis on monitoring

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to : use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have :

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 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 handle multiple tasks with conflicting deadlines.

Proactivity and assertively when communicating with internal team members 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.

Alexion Canada

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Alexion 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. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

Date Posted

28-Nov-2024

Closing Date

19-Dec-2024

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.