Shilpa Kulkarni

Research Assistant · Administrative Assistant · Associate · Clinical Trial Specialist · Regulatory Affairs Coordinator

My training and experiences closely line up with the role of Start Up Specialist.My relevant qualifications include my University degree in Medicine. As a detail-oriented Startup Specialist, I have efficiently coordinated and supported submissions in the UK, Ireland, and EU countries, demonstrating timely and concise communication and facilitating the daily operations of the study. I have thorough knowledge of ICH-GCP guidelines and keep myself updated with the latest changes in the guidelines.

I strongly believe that for the success of any project, it is very important to have good communication and connection amongst all the team members. Through my experience, I have gained the ability to integrate superior operational, organization, and communication skills across all levels of research, allowing me to excel in both independent and team-oriented environments. I am well-versed in activities related to the Study startup, including Site communication and interactions with the regulatory authorities. I also possess proficiency in Microsoft Office tools as well as CTIS (for EU) and IRAS portal (For UK). I have handled multiple projects with differing priorities at the given time. I have handled Phase I, II, and III trials.