Clinical Research Associate

1 day ago

Mississauga, Canada AstraZeneca Full time

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**Introduction to role**:
The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s). The CRA works closely with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. Acting as the main contact with the study site, the CRA is responsible for monitoring the study conduct to ensure proper delivery. The CRA prepares, initiates, monitors, and closes assigned sites in clinical studies, following AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. A CRA with longer tenure and experience may take on additional responsibilities associated with LSAD.

**Accountabilities**:

- Contributes to the selection of potential investigators.
- Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles.
- Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
- Actively participates in Local Study Team (LST) meetings.
- Contributes to National Investigators meetings, as applicable.
- Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
- Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies (ISF, etc), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable.
- Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visits.
- Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan.
- Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
- Ensures data query resolution in a timely manner.
- Works with data management to ensure robust quality of the collected study data.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
- Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
- Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
- Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required.
- Assists site in maintaining inspection-ready ISF.
- Prepares for and collaborates with activities associated with audits and regulatory inspections in liaison with LSAD and CQAD.
- Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate.
- Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
- Provides feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable.
- Collaborates with local MSLs as directed by LSAD or line manager.

**Essential Skills/Experience**:

- Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).
- Excellent knowledge of inte

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