Bangalore, Pune; Clinical Research Associate; B.Pharm, M.Pharm; Novotech Australia Pty Limited

Experience
1 - 2 years
The Role
The core focus of the CRA role is to ensure the rights and the wellbeing of the trial participants are protected and the reported trial data is accurate, complete and verifiable from source documents.
The CRA is also the primary link between Investigational sites and Sponsor, acting as a site manager ensuring that clinical trials are conducted and documented as per ICH GCP guidelines, global and local regulatory requirements and Novotech/Client SOP’s
Additional Responsibilities:

• Managing and maintaining study files and documentation ensuring high levels of accuracy

• Logging and tracking of study documentation and trial progress and recording dispatch of study supplies

• Arranging and attending internal and external meetings, assisting in the production of presentation materials, generating meeting minutes

• Contacting external and internal individuals to collate relevant study information and assist with study payments

Who you are

We are looking for CRAs with around 1-2 years site management and monitoring experience, gained in pharma or a CRO. It is considered essential that you have a solid knowledge of GCP, national and international regulations and a sound understanding of how they

apply to you. You will also need to have excellent interpersonal and team skills and genuine commitment to contributing to the development of innovative treatments to fulfil unmet medical needs. Previous experience in respiratory and/or oncology studies is desirable but not essential.


Education and qualification:

· Educated to degree level (biological science, pharmacy or other health-related discipline preferred), equivalent nursing qualification or other equivalent experience

· Diploma/degree in clinical research

· Fluent in English and the local languages.

· Computer literate-proficient with MS office.


send resumes to: novocareers@novotech-cro.com