Ajish Nair

Act as the functional lead for Centralized Monitoring activities in a study. Access management of study team to various clinical research platforms. Act as an Un-blinded Clinical lead. Leading other CMLs, Centralized monitors and Centralized Monitoring assistants to support CRA and CTA with site management. Track study budget and coding hours of clinical team. Have competitive knowledge of CTMS. Overall responsible for eTMF. Manage site payments. Lead the Centralized Monitoring team in client calls.

- Provide site support with issues related to eCRF data entry, missing data and query resolution. - Coordinate with lab vendors for sample shipments - Coordinate with IXRS team for IP shipments - Support CRA with site visits by preparing i-Sitepacks. - Support CTA in collecting missing documents for eTMF. - Send blast email to sites for study updates or newsletters. - Have competitive knowledge of systems like CTMS and various eCRF and IXRS platforms like RAVE, InForm, Endpoint, DrugDev, etc.

Perform retrospective and in-process audits of clinical facility. Prepare audit reports and ensure quality compliance to GCP and applicable regulations. Audit and approve calibration of instruments. Ensure SOP compliance in important activities like screening of volunteers, IMP dispensing, dosing, etc. Perform audit of protocol, source data and clinical study report. Release QA statement.

Act as a site coordinator and clinical pharmacist for BA/BE, Phase-1 and Nutraceutical studies. Impart Protocol and SOP training to site staff. Departmental SOP creation and revision of existing SOPs. Assisting QA in resolving regulatory queries. Face Regulatory inspections and sponsor audits. Oversee the pharmacy activities like IMP receipt, accountability, dispensing, temperature controlled shipments and disposal/return procedure, maintenance and calibration of pharmacy equipments.