Job Description

Short role description:The Oncology Clinical Research Associate (CRA) has local responsibility for the delivery of the oncology studies (recruitment and quality data collection) at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Manager to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the PI and co-PI, and the overall study site staff and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Local Study Associate Director.
CRAs might have different internal titles based on the experience level (Associate CRA, CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The SMM Country Head may assign this internal title after confirmation with Cluster Director SMM/Senior Director SMM (Region). This will only be applicable for countries which have been exempted to use tiered internal titles.Typical Accountabilities:

• Gives to the selection of potential investigators.
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• 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.
• Supplies 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 intensifies 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 LSM 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 entry and 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 feed-back 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 calling out 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 the 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\xe2\x80\x99s 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 collaborators for site study delivery (eg MSLs, Site Engagement Lead where applicable).
• Identify issues at sites; resolve issues and bring up as appropriate involving local collaborators and LSADs
• Support the implementation of innovative processes and technologies

Education, Qualifications, Skills and Experience
Crucial:

• Bachelors degree or equivalent experience in related subject area, preferably in life science.
• 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

Desirable:

• Ability to work in an environment of remote collaborators.
• Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and supply to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.

Date Posted 23-Mar-2024Closing Date 28-Mar-2024AstraZeneca 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.

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