ANJALI RAMACHANDRAN

• Handling phase III studies in the therapeutic area Respiratory
• To identification of new sites for clinical trials, analyses site capability, and perform site feasibility for the assigned study
• Performing site selection visits, site initiation visits, Site monitoring visits, and Close- out visits as per the ICH-GCP, protocol SOPs, and regulatory requirements
• Assure continual protocol, SOP, ICH-GCP, and regulatory requirements compliance (informed consent process, source data verification, eCRF, AE and SAE reporting, protocol).
• Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
• Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
• Conducted meetings with sponsor representatives to discuss clinical study developments.
• Followed drug storage procedures to comply with protocols and SOP requirements.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.

• Monitoring the trial throughout the specified duration involves monitoring visits to the clinical trial sites for the therapeutic area Oncology
• Contribute to the identification of new sites for clinical trials, analyses site capability, and perform site feasibility for the assigned study
• To conduct pre-site selection visits (PSSV), site initiation visits (SIV), site closeout visits (SCV), and site monitoring visits (SMV)
• Training the study staff in standard operating procedures for the clinical trials as per applicable regulatory requirements
• Verify that IRB/IEC operates and complies as per GCP, SOP, and applicable regulatory requirements
• Source data validation
• Informed consent form review, case report form (CRF) review, electronic case report form (eCRF) review, investigational adverse event (AE) review, and serious adverse event (SAE) review
• Writing visit reports, filing, and collecting trial documentation and reports from the site
• Verify that the investigator and the investigator’s team are adequately trained and comply with the protocol
• Established drug trial methodologies and procedures to support business and clinical trial endeavors.

• Monitor for WHO trial
• Monitored phase III studies for the therapeutic Orthopaedic, Ophthalmology studies
• On site monitoring with a focus on data integrity and patient safety
• Ensuring AE/SAE is reported appropriately, accurately, and timely manner and that follow up activates are conducted necessary
• Source data verification
• Conducting Pre site selection visit (PSSV), Site Initiation Visit (SIV), closeout visit
• Reviewing CRF, eCRF inform concern documents, all study related documents.

As a CRC, there were some responsibilities as Clinical Research Associate (CRA).

Responsibility of the CRC:

• Handled Cardiology, Diabetes, and Neurology phases III and IV
• Assist the principal investigator at the site.
• Scheduling patient visits and study procedures as per protocol.
• Managing the day-to-day activities of a study.
• Patient screening and recruitment.
• Completing and ensuring the quality of case report forms.
• Drug dispensing and accountability.
• Ensuring proper documentation in the source document.
• SMV preparation, attendance, audits, and close-out visits.

Responsibility of the CRA:

• Site identification, evaluation, and preparation (PSSV).
• Conducting feasibility studies.
• Reviewing the case report forms.
• Investigator identification and evaluation.
• Monitoring the trial site.
• Tracking the status of all study activities

• As the intern CRC assisting the CRC with the study got familiar with the study-related work
• Handled an institutional observational study
• Study drug accountability
• Proper documentation of source documents.