AstraZeneca Pharmaceuticals LP Clinical Research Associate in Warsaw, Poland
Clinical Research Associate has local responsibility for the delivery of the studies at allocated centres and are active participants in the MC study team(s). The Monitor works in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. The Monitor 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.
Obtain and maintain essential documentation in compliance with ICHGCP,
AZ Procedural Documents and local regulations both in the office and at site.
Actively participate in local Study Delivery Team meetings.
Contribute to the selection of potential investigators.
Train, support and advise Investigators and site staff in study related matters.
Contribute to national Investigators meetings.
Initiate, monitor and close study sites in compliance with AZ Procedural
Documents. Share information on patient recruitment and study site progress within local Study Delivery Team.
Drive performance at the sites. Proactively identify study-related issues and escalates as appropriate.
Update IMPACT and other systems with data from centres as per required timelines.
Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
Perform source data verification according to SDV plan.
Ensure data query resolution.
Ensure accurate and timely reporting of Serious Adverse Events.
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
Provide the required monitoring visit reports within required timelines.
Work with data management to ensure quality of the study data.
Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Minimum Requirements and Preferred Background:
University degree in related discipline, preferably in life science, or equivalent qualification.
Fluent knowledge of spoken and written English and Polish.
Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
Good knowledge of relevant local regulations.
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.
Competencies and Skills:
Ability to deliver quality according to the requested standards.
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.
Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
Good analytical and problem solving skills.
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
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.
Next Steps – Apply today!
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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 only employs individuals with the right to work in the country/ies where the role is advertised.