Clinical Research Associate

Clinical Research Associate

Location: CDMX/GDL/MTY

Hybrid work ( 3 office days)

Primarily responsible for coordinating the various aspects of clinical trials. Works as part of a clinical delivery team providing support, guidance and advice on a local level.  Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery. Able to solve complex problems within a range of studies.

What you’ll do

The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated centres and are active participants in the MC study team(s). The CRA works in close collaboration with other CRAs and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner.

The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials.

A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with with Lead CRA, Senior CRA , Local Study Team Leader (LSTL).

Typical Accountabilities

• Ensures the processes for Study Delivery are executed through the development of study reports tools, facilitation of the study delivery system and maintenance of the system.
• As an expert, ensures delivery of a centrally managed study management service across clinical studies from start up to reporting
• Serve as main contact and works closely with the Document Management group until the Clinical Study Report is finalised
• Initiates and maintains production of study documents, ensuring template and version compliance
• Creates or imports clinical-regulatory documents into the Global Electronic Library according to the Global Document List
• Interfaces with Data Management Centre or Data Management Enablement representatives to facilitate the delivery of study related documents
• Manages and coordinates tracking of study materials and equipment
• Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies
• Acts as a technical owner within Patient Safety with a deep understanding of processes and internal regulations
• Keeps own knowledge of best practices and new relevant developments up to date
• Liaises with compliance team members to improve regulatory processes within the team
• Identifies opportunities to improve the methodology and provide practical solutions for clinical development

Essential for the role

• Bachelor degree ( with official recognition.
• Good knowledge of relevant local regulations.
• 2+ years of experience in site monitoring.
• Good medical knowledge in 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.
• Ability to travel nationally as required.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

AstraZeneca is an equal opportunity employer.

AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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 authorisation and employment eligibility verification requirements.