The Clinical Research Associate (CRA) is responsible for the local delivery of clinical studies at assigned sites, acting as the main contact for monitoring study conduct to ensure proper delivery according to guidelines and regulations. This involves preparing, initiating, monitoring, and closing assigned sites, training site staff, driving site performance, and ensuring data quality and compliance.
Requirements summary
Essential requirements include a Bachelor's degree in a related life science discipline or equivalent, excellent knowledge of ICH-GCP guidelines, basic knowledge of GMP/GDP, and good knowledge of relevant local regulations. Candidates must possess excellent attention to detail, strong communication and collaboration skills, and the ability to travel nationally/internationally.
bachelor degreeCommunication SkillsNegotiation SkillsCollaboration SkillsMedical KnowledgeAttention To DetailsICH-GCPMonitoring VisitseTMFCTMSGMP/GDPClinical Study ManagementLocal RegulationsSource Data VerificationData Query ResolutionRisk Based Quality ManagementSource Data Review
Job description
At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.
Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work.
We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.
Introduction to role The Clinical Research Associate (CRA) has local responsibility for the delivery of studies at allocated sites and is an active participant in the local study team(s).
The CRA works closely with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner.
Acting as the main contact with the study site, the CRA is responsible for monitoring the study conduct to ensure proper delivery.
The CRA prepares, initiates, monitors, and closes assigned sites in clinical studies, following AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations.
A CRA with longer tenure and experience may take on additional responsibilities associated with LSAD.
Accountabilities Contributes 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.
Contributes to National Investigators meetings, as applicable.
Benefits
Contract Benefits Program
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 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 LSAD 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.
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 feedback 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 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 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’s 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 MSLs as directed by LSAD or line manager.
Essential Skills/Experience Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
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 skills.
Ability to travel nationally/internationally as required.
Valid G driving license Desirable Skills/Experience 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 add value 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.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Familiar with risk-based monitoring approach including remote monitoring.
Good cultural awareness.
Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
AstraZeneca is committed to accommodating persons with disabilities.
Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailingAZCHumanResources@astrazeneca.com.
