The Oncology Clinical Research Associate (CRA) is responsible for the delivery of oncology-hematology studies, focusing on recruitment and quality data collection at designated sites. As a key member of the local study team, the CRA collaborates closely with other CRAs and the Local Study Manager to ensure timely and efficient study completion. Acting as the primary contact for the Principal Investigator (PI) and site staff, the CRA ensures proper study conduct and compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.

Accountabilities:

- Contributes to the selection of potential investigators (Site Qualification Visits).
- 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.
- 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 within the LST.
- Drives performance at the sites and proactively identifies and resolves study-related issues.
- Updates CTMS and other systems with data from study sites as per required timelines.
- Manages study supplies, drug supplies, and drug accountability at study sites.
- Prepares study drug for destruction, if applicable.
- Performs monitoring visits (remote and onsite) and remote data checks according to the Monitoring Plan.
- Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV).
- Conducts regular Site Quality Risk Assessments and adapts monitoring intensity accordingly.
- Ensures timely data entry and query resolution.
- Works with data management to ensure robust quality of collected study data.
- Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
- Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator.
- Follows up on outstanding actions with study sites to ensure timely resolution.
- Escalates systematic or serious quality issues to Local Management and/or CQM as required.
- Assists sites in maintaining inspection-ready ISF.
- Prepares for and collaborates on activities associated with audits and regulatory inspections.
- Ensures timely collection/uploading of essential documents into the eTMF.
- Supports/participates in regular QC checks performed by LSAD or delegate.
- Ensures all study documents are available and ready for final archiving.
- Provides feedback on research-related information useful for the local market.
- Ensures compliance with AstraZeneca’s Code of Ethics, company policies, and procedures.
- Ensures compliance with local, national, and regional legislation.
- Collaborates with local stakeholders for site study delivery.
- Identifies issues at sites; resolves issues and escalates as appropriate.
- Supports the implementation of innovative processes and technologies.

Essential Skills/Experience:

- CRA monitoring experience with onco-hematology
- Bachelor's degree in life science
- Preferably based in São Paulo or Porto Alegre
- Ability to travel nationally
- Excellent knowledge of spoken and written English (Fluent or Advanced is required)
- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
- Good knowledge of relevant local regulations
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas
- Basic understanding of the drug development process
- Good understanding of Clinical Study Management including monitoring, study drug handling, and data management

AstraZeneca empowers its employees to act swiftly on smart risks, keeping ahead in the fast-paced Oncology field. We prioritize bold moves, enabling fearless decision-making that follows scientific evidence. Our collaborative environment fosters diverse knowledge sharing across teams, driving us to challenge norms and learn from failures. With one of the broadest Oncology pipelines in the industry, we offer numerous opportunities to work with novel drugs and make significant impacts on patient outcomes.

Join us in pushing the boundaries of science to transform cancer treatment. Apply now!

Date Posted

Closing Date

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.