Bhavi Kadakia Email & Phone Number

Melbourne, Victoria, Australia

Melbourne, Victoria, Australia

Melbourne, Victoria, Australia

• Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF), conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP.• Support the clinical team in essential document development, collection and management process.• Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF’s, ensuring accuracy and completeness of the data.• Create the Investigator Site Files.•Assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.•Assist in IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.• Assist with site specific Clinical Trial Agreement (CTA) and budget negotiation. • Take a responsibility of submission and tracking of Investigator payments in CTMS and any finance system. Complete study finance reconciliation as requested by the CRA, ensuring subjects activities are updated.• Assist with vendor management updates, tracking and payments as requested by the CRA including updating laboratory normal reference ranges. •Track and report study SUSARs/CIOMS to the relevant stakeholders, i.e., Regulatory Authorities, Investigators and Sponsors according to the Safety Management Plan and Clinical Monitoring Plan.Achievements:•I coordinate 10 clinical trials of various therapeutic areas across a total of 30 sites. •Additionally, I participated in an FDA Audit for a clinical trial that has been ongoing since 2015, which involved 21 sites in Australia. As part of my role, I visited 9 of sites to assist the Clinical Research Associate (CRA) for the review of the (ISF) in preparation for the Audit.•Novobuddy to new starters.

Melbourne, Victoria, Australia

Exam invigilator at Swinburne University, Hawthorn.

Melbourne, Victoria, Australia

• According to the specific role (Central or Local), coordinated, managed and completed functions on assigned trials activities detailed on the task matrix.• Performed department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.• Supported the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.• Provided system support (i.e., GoBalto & eTMF).• Performed administrative tasks on assigned trials including but not limited to timely processing ofdocuments sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings andcommunications as needed, providing documents and reports to internal team members.• Reviewed and tracked local regulatory documents.• Transmitted documents to client and centralized IRB/IEC.• Analysed and reconciled study metrics and findings reports. Assisted with clarification and resolution offindings related to site documentation.• Maintained vendor trackers.• Assisted with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacybinder materials and non-clinical study supplies to sites.• Assisted with study-specific translation materials and translation QC upon request.Achievements:I coordinated 12 clinical trials of various therapeutic areas across a total of 25 sites. I also Mentored and supervised two junior Clinical Trial Coordinators, providing guidance and support in their professional development. I also performed the duties of a CRA and helped closing out a study.

Melbourne, Victoria, Australia

• Worked as part of the COVID Vaccination clinic team (Royal Exhibition) to provide administrative assistance to the St Vincent’s COVID Vaccination clinic.• Also worked as a Frontline Healthcare worker as a temperature tester.

Melbourne, Victoria, Australia

•Achieve established average per hour (APH) counting goals while ensuring accuracy and integrityof the data collected in all inventories worked.•Ability to work assigned shifts and adhere to a flexible schedule with varying hours to includeworking an extreme schedule, resulting in long hours on occasion.•Ability to maintain a high level of confidentiality in all duties.

Melbourne, Victoria, Australia

Project A: Victorian Government Report. I as an intern at CCRM, was challenged to develop a sector development plan to put Australia on the path of advancing its regenerative medicine industry. I also researched about the state of the art of the science and different translation and commercialisation strategies adopted by leading jurisdictions around the world such as the US, the UK and Japan. Also, collated recommendations in building a strong and effective manufacturing presence capable of supporting translation and commercialisation efforts published by leading institutions and thinkers.Project B: Market analysis.Analysis and assessment of the international market and opportunities of Regenerative Medicine in Australia. I as an intern at CCRM, Australia have focused on analysing the market of a disease, specifically “Leukaemia”.Accomplishment: Victorian Government Report. As an intern at CCRM, I assisted to draft a report to assess thecurrent global cell and gene therapy capabilities and about Australia’s preparedness for new advanced therapies. The report was submitted to the Victoria Government and was highly acknowledged and appreciated. The report is currently put in front of the minister for consideration and backed by the Department of Jobs, Precincts and Regions

Master'S Degree, Biotechnology

Bachelor'S Degree, Biomedical/Medical Engineering