Naila Khan Email and Phone Number

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.• Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Collaborate and liaise with study team members for project execution support as appropriate.• Accountable for supporting development of project subject recruitment plan on a per site basis.• Accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Assist with periodic review of study files for completeness.• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Coordinate the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.• May collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Assist with periodic review of study files for completeness.Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.Accompany CRAs on site visits to assist with clinical monitoring duties.

Worked in Livzon Project Sponsored by China. It is a Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID19 in Healthy Adults Aged 18 Years and Older after the Vaccination of 2 Doses of Inactivated Vaccines.My duties included: • Counselling of participants regarding study objectives• Randomization• Diary Card dispensing and receiving• EDC of Covid-19 Case Monitoring• Maintenance of site documents• EDC of patient’s record• Weekly follow-up calls and its EDC• Assisting medical officers in resolving queries• Assisting in ample shipment

• DNA extraction • Gel electrophoresis • Nano drop • PCR • RNA extraction