Clinical Research Associate

Job DescriptionClinical Research AssociateLocation: Sofia, BulgariaDepartment: BioPharma Clinical Operations – Site Management & Monitoring Reporting to: Director Site Management & Monitoring (SMM) / Country Head / Associate Director, SMMAbout the RoleWe are looking for a dedicated Clinical Research Associate (CRA) to take local responsibility for the delivery of clinical studies at assigned sites as an active member of the local study team. Working in close collaboration with other CRAs and the Local Study Associate Director (LSAD), you will act as the primary contact for study sites, monitoring study conduct and ensuring proper delivery in line with AstraZeneca's procedural documents, ICH-GCP, and relevant local regulations. The role encompasses the preparation, initiation, monitoring, and closure of allocated clinical study sites, ensuring each delivers on its commitments within required timelines.Key ResponsibilitiesPerform Therapeutic Area training, including relevant indication and Clinical Study Protocol training, as required for the studyContribute to the selection of potential investigators through the conduct of Site Qualification VisitsSupport study start-up and regulatory maintenance where required, including preparing, reviewing, and submitting documents to Ethics Committees, Institutional Review Boards, and Regulatory AuthoritiesConduct Site Initiation Visits and train, support, and advise investigators and site staff on study-related matters, including principles of Risk-Based Quality ManagementConfirm that site staff have completed and documented all required training to keep sites inspection readyParticipate actively in Local Study Team meetings and Investigator meetings and maintain effective, proactive communication with all stakeholdersInitiate, monitor, and close study sites in accordance with AstraZeneca Procedural Documents and share updates on patient recruitment and site progressDrive site performance by proactively identifying and resolving study-related issues and escalating where appropriateUpdate the Clinical Trial Management System and other relevant systems with study site data within required timelinesManage study supplies, drug supplies, and drug accountability at study sites and prepare study drugs for destruction where applicablePerform remote and onsite monitoring visits and remote data checks as specified in the study-specific Monitoring PlanConduct regular Site Quality Risk Assessments and adjust monitoring intensity accordingly during the studyCollaborate with data management to maintain robust data quality through timely resolution of data queriesEnsure accurate and prompt reporting of Serious Adverse Events and subsequent follow-upsPrepare and finalise monitoring visit reports and provide timely feedback and follow-up letters to Principal InvestigatorsEscalate serious or systematic quality concerns, data privacy issues, or compliance breaches to Local Management or the Clinical Quality Associate Director as neededPrepare for and collaborate on audits and regulatory inspections in liaison with LSAD and CQADCollect and upload essential documents into the electronic Trial Master File in accordance with ICH-GCP, AstraZeneca SOPs, and local requirementsEnsure compliance with AstraZeneca's Code of Ethics and all company policies relating to people, finance, technology, security, and Safety, Health and EnvironmentCollaborate with local Medical Science Liaison Officers as directed by the LSAD or line managerCandidate ProfileBachelor's degree in a related discipline, preferably in life science, or an equivalent qualification aligned to the knowledge and skills of the roleKnowledge of the drug development process, ICH-GCP international guidelines, and relevant country regulationsMedical knowledge and the ability to learn relevant AstraZeneca Therapeutic AreasExperience in Clinical Study Management, including monitoring, study drug handling, and data managementFluency in written and spoken business-level EnglishAbility to travel nationally and internationally as requiredValid driving licence, where this is a country employment requirementStrong personal effectiveness, learning agility, and self-accountabilitySound risk-based thinking, problem solving, and effective issue managementReady to Make a Difference?If you're passionate about clinical research, thrive on leading teams, and want to play a defining role in bringing new medicines to patients — we'd love to hear from you.Apply today and help shape the future of clinical research at AstraZeneca <Bulgaria.Date> Posted27-Aug.-2026Closing Date16-Sep.-2026AstraZeneca 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.