job title: Clinical research associatee (Astrazeneca)

11/6/20252 min read

Roles and Responsibilities

Contributes to the selection of potential investigators for clinical studies.
Trains, supports, and advises Investigators and site staff on study-related matters, including Risk-Based Quality Management (RbQM) principles.
Confirms that site staff have completed and documented required trainings (e.g., ICH-GCP) prior to and throughout the study.
Ensures that all study sites remain inspection-ready at all times.
Actively participates in Local Study Team (LST) meetings and contributes to National Investigators Meetings, as applicable.

(Applicable in countries where CRAs are accountable for start-up and regulatory maintenance)

Conducts Site Qualification Visits (SQVs).
Manages collection, preparation, review, and tracking of documents required for the application process.
Submits required applications/documents to Ethics Committees (ECs)/Institutional Review Boards (IRBs) and Regulatory Authorities for both study start-up and duration.
Ensures regulatory maintenance throughout the study.

Initiates, monitors, and closes study sites in compliance with AstraZeneca (AZ) Procedural Documents.
Shares information on patient recruitment, site progress, and performance with the LST.
Drives site performance by proactively identifying and resolving study-related issues and escalating as appropriate.
Updates Clinical Trial Management System (CTMS) and other systems with study site data within required timelines.

Conducts remote and on-site monitoring visits, and performs remote data checks per the study-specific Monitoring Plan.
Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV) in line with study requirements.
Performs regular Site Quality Risk Assessments and adjusts monitoring intensity as needed.
Ensures timely resolution of data queries and collaborates with Data Management for data quality assurance.
Prepares and finalizes Monitoring Visit Reports (MVRs) in CTMS, providing feedback to Principal Investigators along with follow-up letters as per timelines.
Follows up on outstanding actions to ensure timely resolution.

Ensures accurate and timely reporting of Serious Adverse Events (SAEs) and follow-ups.
Adheres to AstraZeneca’s Code of Ethics, and all company policies related to People, Finance, Technology, Security, and SHE (Safety, Health, Environment).
Ensures compliance with local, national, and regional legislation, as applicable.
Escalates systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues to Local Management and/or Clinical Quality Assurance Department (CQAD).

Ensures timely collection and uploading of essential documents into the electronic Trial Master File (eTMF) per ICH-GCP, AZ SOPs, and local requirements.
Supports and participates in regular Quality Control (QC) checks conducted by LSAD or delegate.
Assists sites in maintaining inspection-ready Investigator Site Files (ISF).
Ensures all study documents under CRA responsibility (e.g., site communications, reports) are ready for final archiving and completion of the local section of the eTMF.

Manages study and drug supplies at the site, including Investigator Site Files (ISF) and drug accountability.
Oversees study drug destruction processes, where applicable.

Prepares for and collaborates in audit and inspection activities in liaison with Local Study Associate Director (LSAD) and CQAD.
Ensures all study sites are audit-ready and compliant at all times.

Collaborates with Medical Science Liaisons (MSLs) as directed by LSAD or line manager.
Provides feedback on research-related intelligence, including investigator performance and competing studies, relevant to the local market.

Actively participates in quality improvement initiatives and contributes to ongoing process enhancements within the clinical operations function.
Maintains awareness of industry best practices, regulatory changes, and AZ procedural updates.