Oncology Clinical Research Associate

AstraZeneca

Jan 11, 2025

Job
Full-time
Junior Level
Research & Development
Healthcare
Milan
Quick Apply

AI generated summary

You need a scientific degree, 2+ years CRA experience, preferably in oncology, strong knowledge of ICH-GCP, medical knowledge, and project management skills. Travel may be required.
You will monitor clinical study sites, ensure compliance, manage documentation, support investigators, resolve issues, and maintain inspection readiness while collaborating with local teams.

Requirements

Scientific Degree or equivalent degree
Minimum 2 years of experience as CRA in a pharma company or CRO
Preferred experience in oncology
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.
Excellent attention to details
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation and problem solving skills
Ability to travel nationally/internationally as required
Valid driving license
Preferred location: Milan and surroundings
Demonstrated project management skills including scope, budget, timeline, resource management and use of associated tools.
Experience from Clinical Research/Operations (i e hands on work with Clinical Trial Management in the pharmaceutical industry)
Knowledge of R&D ways of working
Ability to effectively work with External Service Providers
Ability to look for and champion more efficient and effective methods/processes

Responsibilities

Reporting to the Director SMM, as CRA you will work in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site 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.
Contributes to the selection of potential investigators.
Performs Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents 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.
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 systems with data from study sites as per required timelines.
Manages study supplies, 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 query resolution in a timely manner.
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups.
Prepares and finalises monitoring visit reports in systems and provides timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP.
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 the activities associated with audits and regulatory inspections in liaison with LSM and CQM. Ensures the sites are ready for inspection at all times.
Ensures timely collection/uploading of essential documents in accordance with ICH-GCP, AZ SOPs and local requirements.
Ensures that all study documents under their responsibility are available and ready for final archiving and completion.
Collaborates with local MSLs as directed by LSM or line manager.
Manage all activities and Account relationship according with Company Values, Code of Conduct, Guidelines/Internal procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment) and local, national and regional legislation.

FAQs

What is the location requirement for the Oncology Clinical Research Associate position?

The preferred location for the role is Milan and its surroundings.

What are the essential educational requirements for this position?

A scientific degree or equivalent degree is required for this role.

How many years of experience as a CRA are required?

A minimum of 2 years of experience as a CRA in a pharmaceutical company or CRO is required.

Is oncology experience preferred for this role?

Yes, experience in oncology is preferred but not mandatory.

What are the key responsibilities of the Oncology Clinical Research Associate?

Key responsibilities include site selection, initiation, monitoring and closure of assigned sites, training site staff, ensuring compliance with regulations, and managing study supplies.

Will I have to travel for this position?

Yes, the role requires the ability to travel nationally and internationally as required.

What skills are necessary for effective communication in this role?

Good written and verbal communication skills are essential.

What is the main reporting structure for this position?

The CRA reports to the Director SMM and works closely with other CRAs and the Local Study Team.

Are there any desirable skills mentioned for this position?

Yes, desirable skills include project management experience, knowledge of R&D processes, and the ability to work effectively with External Service Providers.

What guidelines and regulations must the CRA be familiar with?

The CRA must have excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP, and a good understanding of relevant local regulations.

AstraZeneca

What science can do

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. AstraZeneca is a global pharmaceutical company dedicated to improving the health and well-being of people worldwide. With a focus on innovative research and development, AstraZeneca develops and manufactures a wide range of prescription medicines, including treatments for cardiovascular, respiratory, oncology, and other therapeutic areas. Their aim is to transform the lives of patients by discovering, developing, and delivering innovative medicines that address unmet medical needs. AstraZeneca's purpose is to push the boundaries of science and collaborate with healthcare professionals, organisations, and communities to improve patient outcomes and contribute to the advancement of healthcare globally.