Clinical Research Associate

Job Description 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.

Date Posted

27-Aug.-2026

Closing Date

16-Sep.-2026

AstraZeneca 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.