Vrushali Joshi

• Ensures clinical trial documentation is conducted in accordance with written SOP and ICH-GCP guidelines
• Ensures TMF is inspection ready and in alignment with study agreed strategy and applicable milestones
• Monitors and drives TMF completeness and quality for in house and outsourced studies
• Serves as TMF point of contact for any audits and inspections and assist with development of corrective and preventive action plans in response to any findings
• Liaise with full service outsourcing providers who are performing as part of cross functional team
• Assist in development and delivery of training materials and provides subject matter expertise
• Provides project management expertise to global study team as needed to support study deliverable targets to agreed quality and data integrity standards
• Serves as point of contact for study team for TMF matters and liaises with TMF SMEs and process owners to aid in their understanding of requirements and associated solutions to ensure TMF is inspection ready at all times
• Conduct analysis of business issues / opportunities and identifies/ supports implementation of high quality solutions
• Addresses study team and stakeholder requests in timely and efficient manner
• Understand all technical aspects of TMF systems and associated applications.
• Enhanced team collaboration by providing clear communication of complex findings through visualizations and reports.

• Manages set and maintenance of e-TMF in accordance with set TMF processes
• Responsible for mapping sponsor’s e-TMF index, if applicable adds / modifies all approved e-TMF artifacts in Sponsor master index
• Visual quality checks of e-documents prior to release to confirm image clarity and readability
• Perform Functional QC of documents
• Maintains TMF in state of audit readiness for quality and compliance
• Process and track final essential artifacts throughout all phases of study in accordance with Sponsor SOP and applicable regulatory guidelines
• Participate in client audits and regulatory inspections by guided access to e-TMF study area
• Review and respond to e-TMF related queries for further resolution
• Attend internal or external study team meetings as required.

• sponsible to handle project for one of critical clients
• Mentor and coach project team for smooth execution of project related activities
• Responsible for high level QC of e-TMF along with ensuring that all QC work done at CDS I and CDS II levels are complete and accurate and delivered in timely manner
• Also involved in helping to mentor and train new employees with direction from Clinical Document Team Lead and/or Clinical Document Manager
• Responsible for QC2 and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies
• Perform study lead responsibilities, be responsible for assigned studies, and ensure that project runs smoothly from start to end
• Communicate with PMs and team to ensure project timelines are met and good quality TMF is maintained
• Perform internal audit reviews before internal audits to ensure audit readiness
• Liaise with team to drive TMF quality control (QC) review activities during active study phase in accordance with TMF Management plan; this includes QC of clinical documents for compliance with applicable requirements, maintenance of trackers for written notification of findings, and follow-up through resolution of identified TMF deficiencies
• Assist with User Acceptance Testing during product development and release
• Work on cross functional teams including Project Management, Business Development, Client Services, Development, and IT on implementation and management of client projects
• Gather and provide feedback on features and enhancements that may be needed on ongoing basis to Development Team
• Respond to client requests for new project initiatives; collaborate with various members of Production and Sales teams to assess scope of work and produce cost estimates
• Also had opportunity to work for internal audits as auditor to make studies audit ready (for client audit / Regulatory audits).

• Tasks associated: Manage all logistic requirements of study including data collection from study participants and data entry along with assessment
• Assist principal investigator in study related activities for completion
• Assist in presentation preparation for Indian Association for Palliative Care conference
• Maintain record of study related documents
• Involved in research article writing.

RB Coordinator:

• Tasks associated: Manage logistics requirements of each IRB meeting
• Attend all IRB meetings and provide accurate and complete minutes of meeting, distribute minutes to board members for review prior to convened board meeting
• Interact with Investigator and study team to assure completeness and accuracy of records with special attention to timelines
• Respond to IRB related queries/questions and direct them to appropriate individual for consultation if necessary
• Record keeping
• Audit faced: AAHRPP (Association for accreditation of Human Research Protection Programs) held in June 2012
• This organization works to improve systems that protect the rights and welfare of individuals who participate in research
• Faced audit as an IRB coordinator.

Study Start Up Coordinator:

• Tasks associated: Manage activities in completion of feasibility
• Assist Principal Investigator in Site Qualification Visit
• Coordinate with Principal Investigator in completion of essential documents
• Respond to Queries from Sponsor /CRO and complete Study specific tasks till Initiation of study
• Assist Principal Investigator in IRB submission.

• Completed data entry tasks with accuracy and efficiency.
• Verified data files prior to entry to maintain high data accuracy.
• Corrected data entry errors to prevent duplication or data degradation.