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Clinical Research Associate At AstraZeneca

 Clinical Research Associate At AstraZeneca

Clinical Research Associate At AstraZeneca



Do you have expertise in, and passion for, Medical? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!


ABOUT ASTRAZENECA


AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.


BUSINESS AREA


Be part of delivering our vision to be the leader in Cardiovascular, Renal, Metabolism, Respiratory and Immunology by 2025. We need to build on our heritage and think and act differently to evolve with the healthcare landscape. From becoming a digitally enabled enterprise to accelerating launches. It means we are forward-looking, challenge the status quo, reflect on insights, spot opportunities and act on smart risks.


What you’ll do


Implementation of monitoring and recruitment plans, design of CRF completion guidelines, identification of investigators and management of investigator sites. 

Track recruitment and oversee monitoring activities such as timely CRF collection, resolution of data queries, and timely reporting of SAEs. 

Provide appropriate and timely communication of essential information to the project teams.

Provide aid to facilitate timely selection of investigators and sites and recruitment of patients for clinical trials globally. 

Perform source data verification and source data review per SDV plan.

Assist in the creation of sound strategies and best practices to effectively recruit, and retain patients, investigators, and sites for clinical trials. 

Interact with investigators, study site personnel, and vendor/CRO personnel. 

Perform pre-study, site initiation, routine, and close-out monitoring visits to ensure compliance with the protocol, country laws, other relevant regulations, and guidelines.

Assist in the resolution of issues regarding grant negotiations and placement of assessments at assigned investigational sites.

Assist in the final selection of investigational sites. 

Collect and review essential documents for study start-up and ensure documents remain current during the trial.

Maintain AstraZeneca internal trial master file to ensure inspection readiness.

Review clinical data in-house and communicate with study site personnel for resolve data queries.

Responsible for Delivery of IRB/IEC required documents to Investigators for Submission.

Essential for the role


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.


Capabilities:


 Strong understanding of International guidelines ICH/GCP.  GMP/GDP knowledge is an asset

Good knowledge of country relevant local regulations

Medical knowledge in CVRM, Oncology, GI & Respiratory Therapeutic Areas.

Good knowledge of the Drug development process& Clinical Study Management including monitoring, study drug handling and data management.

Effective communication and project management skills

Strong Customer focus

Applicants should possess the following qualifications to go through initial screening:


Bachelors’ degree in pharmacy or equivalent.

Minimum of 1-2 years clinical research experience in on-site monitoring is required, or equivalent, with good track record in the management of clinical investigative sites.

Spoken& Written English Proficiency is a must

Apply Here

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