sunitha murali

Clinical Research Professional with 5+ Years of Experience in Pharmacovigilance
Dedicated to supporting clinical teams in ensuring compliance, data integrity, and efficiency in clinical trials.

• Supported CRAs and RSU teams in updating and maintaining clinical documents and systems, including the Trial Master File (TMF), ensuring timely and accurate tracking of site compliance and performance.

• Assisted with the preparation, handling, filing, and archiving of clinical documentation in adherence to the scope of work and standard operating procedures (SOPs).

• Conducted periodic reviews of study files to ensure completeness and compliance with regulatory requirements.

• Assisted in the preparation, handling, and distribution of Clinical Trial Supplies, maintaining tracking information for accurate inventory control.

• Managed Case Report Forms (CRFs) and resolved queries from the sponsor site to ensure smooth data flow.

• Acted as a central point of contact for the clinical team, facilitating communications and ensuring timely updates on project activities.

• Accompanied CRAs on site visits after required training, providing on-site clinical monitoring support.

University of Bangalore, India | Jun 2004 – Jun 2006

• Clinical Research Coordinator Certification

Northwestern University, Chicago, IL | Jan 2018

• Good Clinical Practice (GCP) Certification
NIDA Clinical Trials Network | Aug 2021

• Transporting Dangerous Goods Training
Mayo Clinic | Aug 2021

• Drug Regulatory Affairs Certification
Udemy | Sept 2022

• eCTD & CTD Preparation & Submission
Udemy | Sept 2022