Ongoing/monitoring phase Responsibilities: -•Lead internal CRA meetings/teleconferences and follow-up with specific tasks.•Prepare agenda, attend Sponsor meetings and prepare meeting minutes and distributing action item to the study team.•Correspond directly with the sponsor to provide information/updates.•Support the PM with vendor management, e.g., central laboratory, IVRS/IWRS providers.•Support the PM in ensuring CRAs are adequately trained on project specific requirements including study protocol, specific procedures, project plans, and related forms and the Case Report Form•Assist with and track the ethics and regulatory submission and approval processes during the course of the study.•Support PM in developing and implementing subject recruitment strategies at the study and site level.•Perform Site Selection visits, Initiation visits and Monitoring visits for the assigned study.•Monitoring CRAs to perform SSVs, SIVs, SMVs, and SCOVs as per timelines.•Review visit reports and site follow-up letters for compliance, provide final approved documents to Sponsor as required and track report metrics.•Oversee safety reporting processes to ensure in line with local and regional regulatory requirements.•Prepare the Project Filing plan and ensure CRA team is trained on TMF filing requirements including submitting required documents for the eTMF on an ongoing basis throughout the project and ensuring TMF Quality Reviews are completed as per the Filing plan•Oversee and coordinate timely reviews and documented reconciliations of the eTMF by the project team at the indicated time points per the project filing plan. •Assist PM with response to audit findings and assist CRAs with completion of any CAPA review and documentation.•Support PM with managing CRA resources to ensure monitoring activities is performed as per plan.•Support PM with finance activities•Comminucate with site CTA and Budget Discussion and Finalization.

• Support and coordinate feasibility, site identification, and site selection activities for assigned studies.• Lead and assist with preparation of initial ethics and regulatory submission.• Support PM with application and tracking Investigational Product (IP) and ancillaries import/export permits and licenses• Review Site Activation Forms and related essential documents.• Prepare for and attend Investigator meetings.• Develop and distributes Source Data Verification/Monitoring tools and trackers• Develop and distribute an annotated report template and template visits confirmation/follow-up letters in accordance with any Sponsor requirements.• Maintain ICF version tracking and assist with ICF translation process if required• Maintain document translation tracking and follow-up with specific translation tasks if required. Ongoing/monitoring phase• Lead internal CRA meetings/teleconferences and follow-up with specific tasks. • Prepare agenda, attend Sponsor meetings and prepare meeting minutes and distributing action item to the study team.• Correspond directly with the sponsor to provide information/updates• Support the PM with vendor management, e.g. central laboratory, IVRS/IWRS providers• Support the PM in ensuring CRAs are adequately trained on project specific requirements including study protocol, specific procedures, project plans, and related forms and the Case Report Form• Assist with and track the ethics and regulatory submission and approval processes during the course of the study• Support PM in developing and implementing subject recruitment strategies at the study and site level• Perform Site Selection visits, Initiation visits and Monitoring visits for the assigned study.• Monitoring CRAs to perform SSVs, SIVs, SMVs, and SCOVs as per timelines. • Review visit reports and site follow-up letters for compliance, provide final approved documents to Sponsor as required and track report metrics

• Management of Clinical Trial Sites • Oversee proper collection of data via 100% SDV• Identification and reporting of PDs/ AEs/SAEs/AESIs.• Track and maintain site status and update. • Perform site level reconciliation of study material (including the IP)• Perform site level finance reconciliation. (subject wise payments made to the site)• Safety monitoring and FU with site still closure of the all the applicable • Ensure that the IMP is stored under appropriate protocol specified conditions and accountability is maintained in-house and at the site• Coordinating flow of information from site to in-house KLINERA CPM• Handling and coordinating all information pertaining to safety issues at site to KLINERA and Sponsor• Ensure all applicable Safety Reports/ CIOMS/ IND letter/s availability on ISF followed by regular reconciliation of EC submission and acknowledgement.• Ensure completeness of CRFs, query resolution and ISF at the site• Ensure subject compliance to study protocols• Be aware of and monitor closely sites for scientific misconduct and any fraudulent practices • Coordinate query resolutions with scheduled timelines• Keep site staff motivated to deliver study activities efficiently• Prompt sites to make necessary EC submissions right from prior to start of the study and • on regular intervals as mandated by ECs (per project need) and at the end of the study• Coordinate CSR review and sign-off by investigators

• Management of Clinical Trial Sites • Track and maintain site status and update. • Perform site level reconciliation of study material (including the IP)• Perform site level finance reconciliation. (subject wise payments made to the site)• Coordinating flow of information from site to in-house KLINERA CPM• Ensure all applicable Safety Reports/ CIOMS/ IND letter/s availability on ISF followed by regular reconciliation of EC submission and acknowledgement.• Ensure completeness CSF at the KlinEra• Ensure subject compliance to study protocols• Be aware of and monitor closely sites for scientific misconduct and any fraudulent practices • Coordinate query resolutions with scheduled timelines• Keep site staff motivated to deliver study activities efficiently• Prompt sites to make necessary EC submissions right from prior to start of the study and • on regular intervals as mandated by ECs (per project need) and at the end of the study

• Review and Completion of Investigator Site File• Perform Clinical Operations: Site feasibility, initiation, monitoring & close-out visits• Team Management• SAE/AE Reporting on EDC (e-CRF), Ethics Committee and DCGI• Monitoring and Auditing (Internal/CRO/Sponsor/Finance/Ethics Committee)• Handling of Intramural /Extramural (Sponsor)Trials/ Thesis/ Publication• Worked on SPSS Analysis System• Submission of New and Continue Projects Documents• Handling and Accountability of Trial Investigational Product• Followed SOP’s and GCP regulations and responsibilities for acquiring and processing of data generated from the studies

• Completion of Investigator Site File• Completion of e-CRF• Perform Clinical Operations: Site feasibility, initiation, monitoring & close-out visits• SAE/AE Reporting on EDC (e-CRF), Ethics Committee and DCGI• Monitoring and Auditing• Schedule Subject’s Visit• Prepare Subject’s Source Documents• Team Management• Handling of Intramural /Extramural (Sponsor)Trials/ Thesis/ Publication• Worked on SPSS Analysis System• Submission of New and Continue Projects Documents• Handling and Accountability of Trial Investigational Product• Day to Day coordination with CRA, Patient, Investigator, Sponsor/CRO, Ethics Committee• Followed SOP’s and GCP regulations and responsibilities for acquiring and processing of data generated from the studies