AstraZeneca Recruitment 2021.AstraZeneca Notification full detailes below.AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its headquarters in Cambridge, England. AstraZeneca has a portfolio of products for major disease areas including cancer, cardiovascular, gastrointestinal, infection, respiratory and inflammation.
Important Vacancy details:Hiring For Clinical Research Associate in AstraZeneca!At Bangalore.Intrested candidates apply .
- Post Name: Clinical Research Associate
- Education:qualified as a pharmacist, physician or a dentist. Data driven, highly scientifically oriented person.
- Experienced:currently working as a CRA/Sr. CRA in a multinational pharmaceutical company or a multinational CRO. Currently responsible for on-site monitoring of phase 2/3 global clinical studies. Candidates from remote monitoring background will not be considered even if they have previous on-site monitoring experience.
- Salary: NA
- Openings: NA
Job Description: Hiring For Clinical Research Associate in AstraZeneca!
- Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in Trial Master File (TMF) and Investigator Study File (ISF).
- Actively participate in Local Study Team meetings.
- Contribute to the selection of potential investigators.
- Train, support and advice 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 Team.
- Drive performance at the sites. Proactively identify study-related issues, solutions 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 by the site.
- Ensure accurate and timely reporting of Serious Adverse Events by the site.
- Prepare for activities associated with audits and regulatory inspections in liaison with local
- Study Delivery Team Lead and CA&A.
- 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).
Additional Responsibilities May Include
- Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
- Ensure timely customization and completion of the CSA for designated studies
- Design draft budget for designated studies according to fSMA requirements
- Track and manage agreed payments at study site level.
- Participate in training and mentoring of new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural documents.
- Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
- Contribute to process improvements, knowledge transfer and best practice sharing.
- Actively share applicable information that may be relevant to Marketing & Sales and the MC Medical Department and in accordance with Corporate
Education, Qualifications, Skills and Experience
- Education: qualified as a pharmacist, physician or a dentist. Data driven, highly scientifically oriented person.
- Experience: currently working as a CRA/Sr. CRA in a multinational pharmaceutical company or a multinational CRO. Currently responsible for on-site monitoring of phase 2/3 global clinical studies. Candidates from remote monitoring background will not be considered even if they have previous on-site monitoring experience.
- Passion for delivery and absolutely non-compromising attitude towards quality.
- Excellent communication skills, and passion to redefine the quality and efficiency standards.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online