Clinical Research Associate

Location: Sofia, Bulgaria

Department: BioPharma Clinical Operations – Site Management & Monitoring Reporting to: Director Site Management & Monitoring (SMM) / Country Head / Associate Director, SMM

About the Role

We 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 Responsibilities

• Perform Therapeutic Area training, including relevant indication and Clinical Study Protocol training, as required for the study

• Contribute to the selection of potential investigators through the conduct of Site Qualification Visits

• Support study start-up and regulatory maintenance where required, including preparing, reviewing, and submitting documents to Ethics Committees, Institutional Review Boards, and Regulatory Authorities

• Conduct Site Initiation Visits and train, support, and advise investigators and site staff on study-related matters, including principles of Risk-Based Quality Management

• Confirm that site staff have completed and documented all required training to keep sites inspection ready

• Participate actively in Local Study Team meetings and Investigator meetings and maintain effective, proactive communication with all stakeholders

• Initiate, monitor, and close study sites in accordance with AstraZeneca Procedural Documents and share updates on patient recruitment and site progress

• Drive site performance by proactively identifying and resolving study-related issues and escalating where appropriate

• Update the Clinical Trial Management System and other relevant systems with study site data within required timelines

• Manage study supplies, drug supplies, and drug accountability at study sites and prepare study drugs for destruction where applicable

• Perform remote and onsite monitoring visits and remote data checks as specified in the study-specific Monitoring Plan

• Conduct regular Site Quality Risk Assessments and adjust monitoring intensity accordingly during the study

• Collaborate with data management to maintain robust data quality through timely resolution of data queries

• Ensure accurate and prompt reporting of Serious Adverse Events and subsequent follow-ups

• Prepare and finalise monitoring visit reports and provide timely feedback and follow-up letters to Principal Investigators

• Escalate serious or systematic quality concerns, data privacy issues, or compliance breaches to Local Management or the Clinical Quality Associate Director as needed

• Prepare for and collaborate on audits and regulatory inspections in liaison with LSAD and CQAD

• Collect and upload essential documents into the electronic Trial Master File in accordance with ICH-GCP, AstraZeneca SOPs, and local requirements

• Ensure compliance with AstraZeneca's Code of Ethics and all company policies relating to people, finance, technology, security, and Safety, Health and Environment

• Collaborate with local Medical Science Liaison Officers as directed by the LSAD or line manager

Candidate Profile

• Bachelor's degree in a related discipline, preferably in life science, or an equivalent qualification aligned to the knowledge and skills of the role

• Knowledge of the drug development process, ICH-GCP international guidelines, and relevant country regulations

• Medical knowledge and the ability to learn relevant AstraZeneca Therapeutic Areas

• Experience in Clinical Study Management, including monitoring, study drug handling, and data management

• Fluency in written and spoken business-level English

• Ability to travel nationally and internationally as required

• Valid driving licence, where this is a country employment requirement

• Strong personal effectiveness, learning agility, and self-accountability

• Sound risk-based thinking, problem solving, and effective issue management

Ready 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.