Clinical Research Associate Vacancies at AstraZeneca, BSc Life Sciences Apply
AstraZeneca India, a global, science-led, patient-focused biopharmaceutical company dedicated to the discovery, development, and commercialization of prescription medicines for serious diseases, is seeking a highly motivated Clinical Research Associate (CRA) to join our team in Bengaluru East, Karnataka, India. As a CRA at AstraZeneca, you will play a vital local role in ensuring the successful delivery of clinical studies at allocated sites. You will actively collaborate with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to achieve study commitments efficiently and on time. Serving as the primary point of contact with study sites, you will be responsible for monitoring study conduct to guarantee proper execution. Clinical Research Associate Vacancies at AstraZeneca, BSc Life Sciences Apply
About AstraZeneca
AstraZeneca is more than just one of the world’s leading pharmaceutical companies. We are a science-led organization with a strong focus on patients.
Job Description
The Clinical Research Associate (CRA) holds local responsibility for the successful execution of studies at assigned sites and is an active and engaged member of the local study team(s). Working in close partnership with fellow CRAs and the Local Study Team/ Local Study Associate Director
(LSAD), the CRA ensures that all study commitments are met in a timely and efficient manner. The CRA serves as the main liaison with the study site and is accountable for diligently monitoring the study conduct to ensure its proper delivery.The CRA is responsible for the comprehensive preparation, meticulous initiation, diligent monitoring, and effective closure of assigned sites involved in clinical studies. All activities must be conducted in strict compliance with AstraZeneca Procedural Documents, international guidelines such as ICH-GCP, and all relevant local regulations. The CRA ensures that the sites perform according to their agreed commitments within each individual study.
A CRA with more extensive experience and a longer tenure may be entrusted with additional responsibilities, potentially encompassing tasks typically associated with an LSAD role. CRAs may have varying internal titles (CRA, Senior CRA) depending on their level of experience.
The determination of the experience level is based on years of experience, performance record, the degree of independence demonstrated in the role, and the capacity to undertake additional tasks or mentor more junior colleagues. The Director, Country Head, in consultation with the Senior Director, Cluster Head, or Executive Director, Regional Head, may assign this internal title.
Typical Accountabilities
- Contributes to the thorough selection process of potential investigators for clinical trials.
- In certain countries, as required, CRAs are accountable for the complete study start-up process and ongoing regulatory maintenance. This may include conducting Site Qualification Visits, meticulously collecting, preparing, reviewing, and diligently tracking all necessary documents for the application process; submitting proper applications and documents to Ethics Committees (EC)/Institutional Review Boards (IRB) and to Regulatory Authorities both for study initiation and throughout the study duration.
- Provides comprehensive training, ongoing support, and expert advice to Investigators and site staff on all study-related matters, including the principles of Risk Based Quality Management (RbQM).
- Confirms that all site staff have successfully completed and properly documented all required trainings, including ICH-GCP training, both prior to the commencement of the study and throughout its duration. Ensures that all assigned sites maintain a state of inspection readiness at all times.
- Actively and constructively participates in all Local Study Team (LST) meetings.
- Contributes to National Investigators meetings, as applicable to the study and local context.
- Efficiently initiates, diligently monitors, and effectively closes study sites in strict compliance with AstraZeneca Procedural Documents. Proactively shares pertinent information on patient recruitment progress and overall study site performance (including site quality) within the Local Study Team.
- Actively drives performance at the assigned study sites. Proactively identifies any study-related issues and ensures their timely resolution, escalating them appropriately as needed.
- Accurately updates Clinical Trial Management Systems (CTMS) and other relevant systems with timely and accurate data obtained from study sites, adhering to required timelines.
- Effectively manages study supplies (including the Investigator Site File (ISF)), investigational drug supplies, and ensures meticulous drug accountability at the study site. Prepares study drug for destruction, if applicable according to study protocols and regulations.
- Conducts monitoring visits (both remote and on-site) and performs thorough remote data checks in accordance with the timelines specified in the study-specific Monitoring Plan. If necessary, determines and discusses the appropriate timing and type of visits with the LSAD.
- Performs comprehensive Source Data Review (SDR), meticulous Case Report Form (CRF) review, and accurate Source Data Verification (SDV) in strict accordance with the Monitoring Plan.
- Conducts regular Site Quality Risk Assessments and adapts the monitoring intensity accordingly throughout the duration of the study based on the identified risks.
- Ensures the timely and accurate resolution of all data queries.
- Collaborates effectively with data management teams to ensure the robust quality and integrity of all collected study data.
- Ensures the accurate and timely reporting of all Serious Adverse Events (SAEs) and diligently follows up on all related information.
- Prepares and finalizes comprehensive monitoring visit reports in the CTMS and provides timely and constructive feedback to the Principal Investigator, including a detailed follow-up letter, within the required timelines and in full compliance with AstraZeneca Standard Operating Procedures (SOPs).
- Diligently follows up on all outstanding actions with study sites to ensure their timely resolution.
- Adheres to quality issue processes by promptly escalating any systematic or serious quality issues, data privacy breaches, or Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required by applicable procedures.
- Provides active assistance to the site in maintaining an inspection-ready Investigator Site File (ISF).
- Prepares for and actively collaborates with all activities associated with audits and regulatory inspections in close liaison with the LSAD and Clinical Quality Assurance Director (CQAD).
- Ensures the timely collection and uploading of all essential documents into the electronic Trial Master File (eTMF) in strict accordance with ICH GCP guidelines, AstraZeneca SOPs, and all relevant local requirements. Actively supports and participates in regular Quality Control (QC) checks performed by the LSAD or their delegate.
- Ensures that all study documents under their direct responsibility (i.e., site documents, relevant communications, etc.) are readily available and prepared for final archiving and the complete finalization of the local part of the eTMF.
- Provides valuable feedback on any research-related information, including insights on sites, investigators, and competing studies, that may be beneficial for the local market.
- Ensures full compliance with AstraZeneca’s Code of Ethics, all company policies and procedures related to people, finance, technology, security, and SHE (Safety, Health, and Environment).
- Ensures strict adherence to all applicable local, national, and regional legislation.
- Collaborates effectively with local Medical Science Liaisons (MSLs) as directed by the LSAD or their direct line manager.
Essential
Education, Qualifications, Skills and Experience
- Bachelor’s degree in a related discipline, preferably in life science, or an equivalent qualification (*).
- Excellent and comprehensive knowledge of international guidelines ICH-GCP, with a basic understanding of GMP/GDP principles.
- Good understanding of all relevant local regulations pertaining to clinical research.
- Good medical knowledge and a strong aptitude to learn relevant AstraZeneca Therapeutic Areas.
- Basic understanding of the overall drug development process.
- Good understanding of Clinical Study Management principles, including monitoring procedures, study drug handling protocols, and data management processes.
- Excellent attention to detail and a high degree of accuracy in all tasks.
- Good written and verbal communication skills, with the ability to interact professionally with site staff and team members.
- Good collaboration and interpersonal skills, fostering positive working relationships.
- Good negotiation skills to effectively address site-related issues and timelines.
- Ability to travel nationally and internationally as required by study needs.
- Proven ability to work effectively in an environment with remote collaborators and virtual teams.
- Manages change with a positive and proactive approach, both for personal growth, team effectiveness, and business objectives. Views change as an opportunity to enhance performance and contribute value to the business.
- Demonstrates the ability to proactively identify and champion more efficient and effective methods/processes for delivering high-quality clinical trials within reduced budgets and timelines.
Desirable
- Good analytical and problem-solving skills, with the capacity to address complex issues effectively.
- Demonstrates the ability to effectively prioritize and manage multiple tasks with potentially conflicting deadlines.
- Familiarity with risk-based monitoring approaches, including remote monitoring techniques.
- Good cultural awareness and sensitivity when interacting with diverse study teams and sites.
- Ability to understand the impact of technology on projects and to effectively use and develop computer skills, making appropriate use of systems/software in an e-enabled environment.
- Team-oriented and flexible; demonstrates the ability to adapt to changing priorities and collaborate effectively within a team setting.
Why AstraZeneca?
At AstraZeneca, we are dedicated to being a Great Place to Work. You will be 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. We foster an inclusive culture that champions diversity and collaboration, and we are always committed to lifelong learning, growth, and development. Join us on an exciting journey to pioneer the future of healthcare.
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