Sandesh Kadam

Detail-oriented B.

Pharm

Graduate with 2 years of Experience in Clinical Research Operations Supporting Global Health care studies.

Experience in clinical trial coordination and regulatory compliance, seeking a Trainee Clinical Trial Assistant/Clinical Research Associate position. Eager to apply my knowledge in study coordination, site monitoring support, data verification, and ICH-GCP guidelines to ensure study integrity, patient safety, and successful trial execution, while continuously advancing my expertise in clinical research within a dynamic organization.

Senior Clinical Research Coordinator - AVD Solutions Site Management Organization (SMO), Satellite Ahmedabad - Ahmedabad

(2025-09)

• Identify new sites PI's and conduct the detail protocol specific feasibility.
• IRB/IEC Submission and Approval.
• Ensure and adherence to regulations and submit necessary documentation.
• Set-up maintain and timely updated of Trial Master File (TMF) and relevant binder files.
• Assisting to principal investigator in administrating the inform consent form process.
• Co-ordinate, organize and maintain all study documentation including case report forms, study protocol and regulatory binders, site master file, patient binders and to ensure the quality of data.
• Pre-screening, Screening, Enrolling and Recruiting Subjects.
• Manage Clinical Trial Materials, Accountability, Distribution, Logistics at Site.
• Responsible for co-ordination with lab and other trial related service vendor as per the study requirements.
• Filling the Case Report Forms (CRF) and electronic Case Report Forms (eCRF) and resolving all Queries within Timeline.
• Prepare and participate in audits conducted by QA, sponsors and regulatory authorities.
• To perform internal audit for good quality documentation and data management at various site.
• Maintaining Calibration Records of Instruments used for the Trial.
• Participate in quality and process improvement to create and maintain a well-performing and efficient team.
• Work with department supervisor/manager to assist and train new hires in the research department.
• Work on Intuitional/Independent EC registration, SAE Reporting on SUGAM portal.
• Actively participate in Investigator Meetings (IMs) as required to ensure to update the knowledge and information about the study.
• Assisted in training site staff on study protocols and documentation requirements.

Clinical Research Coordinator - Rudraksha Institute of Medical Sciences - Ghodasar, Ahmedabad

(2025-04 - 2025-08)

Site Coordinator - Sheth Vadilal Sarabhai General Hospital - (S4 Research pvt Ltd Site Management Organization) - Ahmedabad

(2024-11 - 2025-03)

Trainee Clinical Research Coordinator - Vishwaraj Hospital - (Sovarian Clinical Research Site Management Organization) - Pune

(2024-05 - 2024-10)

Bachelor of Pharmacy - Pharmacy - Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad, Pune, Maharashtra (2021 - 2024)