Dr. Afreen Shaik Email & Phone Number

India

Hyderabad, Telangana, India

India

• Preparing, Planning and Organizing the Site Initiation, Monitoring and Close-out Visits.
• Prepare and submit visit SQV, SIV, SMV, SCV reports in a timely manner.
• Involving in recruiting the potential Principal Investigators, Preparation of Independent Ethics Committee / Independent Regulatory Board (IEC / IRB) submissions, notifications to Regulatory Authorities and other tasks.
• Oversees all aspects of Study site management to ensure high quality data resulting in low query levels and good quality assurance reports.
• Execute trials as per ICH-GCP guidelines and SOP of the Organization.
• Communicate effectively with site personnel and review the Trial procedures at sites to minimize the errors that profound during the trial.

India

• Responsible for conducting clinical trials as per protocol as per GCP guidelines under the supervision of Principal investigator(PI). Supported and coordinated the daily clinical trial activities and plays a critical.
• Possessed a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol in order to be able to answer all questions pertaining to the study posed during the informed.
• Coordinated with the approval of new study agreements and contracts.
• Coordinated and attended sponsor Site Selection visits, Routine monitoring visits, and study close out visits.
• Completed case report forms. Extracted data from patient file (Source documents) in a timely manner. Responded to data clarification requests in a timely manner.
• Coordinated with PIs and department to help ensure that clinical research and related activities are performed in accordance with protocol, SOP, GCP and applicable regulatory requirement.

Secondary School Of Education, A

Intermediate, A

Doctor Of Pharmacy - Pharmd, A+

Doctor Of Pharmacy - Pharmd