Sandesh Kadam

Clinical Research Professional

Talent

Greater Ahmedabad AreaMember since June 12, 2026

Project CoordinationClinical Trial Management (Phase I - IV)Site operations & Investigator managementEthics Committee and Regulatory Submission (SUGAM)Regulatory and ethical compliances (ICH-GCP, NDCT Rule 2019, IRB/IEC)AE/SAE Documentation and safety narrativesData management and Query ResolutionSite Documentation Specialist (TMF, ISF)

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About

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.

Experience

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.