Senior CRA

AccountabilitiesContributes to the selection of potential investigators.Accountable for study start-up and regulatory maintenance in some countries.Trains, supports, and advises Investigators and site staff in study-related matters.Confirms completion of required trainings by site staff.Actively participates in Local Study Team meetings.Contributes to National Investigators meetings.Initiates, monitors, and closes study sites in compliance with AZ Procedural Documents.Drives performance at the sites and resolves study-related issues.Updates CTMS and other systems with data from study sites.Manages study supplies and drug accountability at study sites.Performs monitoring visits and remote data checks.Conducts Source Data Review, Case Report Form review, and Source Data Verification.Performs regular Site Quality Risk Assessments.Ensures timely data query resolution.Works with data management to ensure quality of collected study data.Ensures accurate reporting of Serious Adverse Events.Prepares monitoring visit reports and provides feedback to Principal Investigator.Follows up on outstanding actions with study sites.Escalates quality issues as required.Assists site in maintaining inspection-ready ISF.Prepares for audits and regulatory inspections.Ensures timely collection/uploading of essential documents into eTMF.Provides feedback on research-related information useful for the local market.Ensures compliance with AstraZeneca’s Code of Ethics and relevant legislation.Collaborates with local MSLs as directed.Essential Skills/ExperienceBachelor's degree in related discipline, preferably in life science, or equivalent qualification.Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.Good knowledge of relevant local regulations.Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.Basic understanding of the drug development process.Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.Excellent attention to details.Good written and verbal communication skills.Good collaboration and interpersonal skills.Good negotiation skills.Ability to travel nationally/internationally as required.Valid driving license.Desirable Skills/ExperienceAbility to work in an environment of remote collaborators.Manages change positively for self, team, and business.Champions efficient methods/processes for delivering quality clinical trials.Good analytical and problem-solving skills.Ability to prioritize and manage multiple tasks with conflicting deadlines.Familiar with risk-based monitoring approach including remote monitoring.Good cultural awareness.Ability to understand the impact of technology on projects and develop computer skills appropriately.Team-oriented and flexible; responds quickly to shifting demands.Great People want to Work with us Find out why:GTAA Top Employer Award for 10 yearsTop 100 Employers AwardCanada’s Most Admired Corporate CultureLearn more about working with us in CanadaView our YouTube channelAre you interested in working at AZ, apply todayAstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca 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 AZCHumanResources@astrazeneca.com.Date Posted 04-Nov-2025Closing Date 17-Nov-2025AstraZeneca 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. #J-18808-Ljbffr