Harshal Rawool Email & Phone Number

Mumbai, Mh, In

Ahmedabad, Gujarat, India

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Mumbai Area, India

Mumbai Area, India

Mumbai, Maharashtra, India

 In-house CTA  Support Clinical Project Managers and CRAs with their tasks within project timelines Collaborate with CPMs, CRAs and Start-Up Specialists on the preparation, handling, distribution, filing and archiving of clinical documentation and reports. Assist with periodic reviews of the study files and completeness. Act as central contact for the clinical team for designated project communication, correspondence and associated documentation. Maintenance of eTMF… Show more  In-house CTA  Support Clinical Project Managers and CRAs with their tasks within project timelines Collaborate with CPMs, CRAs and Start-Up Specialists on the preparation, handling, distribution, filing and archiving of clinical documentation and reports. Assist with periodic reviews of the study files and completeness. Act as central contact for the clinical team for designated project communication, correspondence and associated documentation. Maintenance of eTMF (filing, uploading and indexing of the documents). Responsible for periodic reviews. Coordinating for documents with sites and internal stake holders.  Responsible for coordinating with the sites for invoices and accruals. Review the invoices as per the agreement. Responsible for timely coordinating with the global team and the shipment vendor for:o Import of Drugso Making sure that the quantities are correcto Making sure that the Import Licenses are requested on time. Prepare documents for regulatory submissions, coordinate and assist the regulatory team for submissions on the SUGAM portal. Worked on the below regulatory submissions:o Global Clinical Trial Application (Form CT-04)o Import license (Form CT-16)o Major/Minor Amendments, etc.o Notifications – Site additions, CSA and EC approval letters. Show less

Thane, Maharashtra, India

 Role - Global and Regional Clinical Trial Assistant (CTA) for North America, Latin America, Europe and Asia Pacific regions. Subject matter expert and responsible generating for Monthly Monitoring Plan Interval Report which captures CRA site visit metrics for all the trials in the department.  Accountable for capturing metrics for other CTAs. Provide support to Protocol Team Leads (PTL) and Clinical Research Associates (CRA) to ensure quality deliverables are submitted by… Show more  Role - Global and Regional Clinical Trial Assistant (CTA) for North America, Latin America, Europe and Asia Pacific regions. Subject matter expert and responsible generating for Monthly Monitoring Plan Interval Report which captures CRA site visit metrics for all the trials in the department.  Accountable for capturing metrics for other CTAs. Provide support to Protocol Team Leads (PTL) and Clinical Research Associates (CRA) to ensure quality deliverables are submitted by appropriate deadlines for any stage of a clinical trial.  Accountable for below tasks in the CTMS:o Creating trial sites o Maintaining and updating site status in CTMS.o Timely create new subjects and enter subject visit data entry in the CTMS.o Make sure that milestones are entered or populated correctlyo Maintaining contacts and accounts in the database (Principal Investigator, Sub Investigator, Study Coordinator, etc.)o Associating the correct contacts to the sites. Responsible for creating, releasing and withdrawing study specific eTraining documents. Responsible for timely maintenance and transfer of study milestones (FPV, FPET, FPETx, LPET, LPETx, LPV).  Investigate and resolve discrepancies with data transfer (milestones, subjects, subject statuses, etc.). Develop Study Fact Sheets, Manage InForm access and occasionally responsible for meeting minutes. Responsible for compiling of DC (InForm) reports on a bi-monthly basis for PTLs to distribute to study teams so they are aware of open and answered queries, missing items, missing forms, blank forms, safety mailings etc. at their assigned sites.  Assemble monthly metric capture reports for PTLs and CRA Line Managers for Training compliance, Monitoring Intervals, Protocol Deviations and Action Items. Employed tools for process improvement for monthly activities which enabled effective resource utilization and management.  Train and mentor new joiners with regards to processes. Show less

Mumbai Area, India

Mulund, Mumbai

Assistant Professor in Department of ZoologyTheory and Practicals: Toxicology, Molecular Biology, Genetics, Biostatistics, Enzymology, EvolutionTechniques: PCR, Electrophoresis, Chromatography, Aseptic handling and culturing of bacteria, PTC, ATC, Animal Handling (Rodents), DNA extraction. Plasmid extraction, etc.

Lecturer in Department of Zoology

Mulund, Mumbai, India

Teaching and guiding students appearing for National Talent Search Scholarship exams.

Master Of Science (M.Sc.), Zoology/Animal Biology, First Class With Distinction

1. Worked on a University of Mumbai sanctioned project, ‘The Study of Ecological Relation of Avifauna and Flora of Mulund, Mumbai’.

Bachelor Of Science (B.Sc.), Zoology/Animal Biology, First Class

Won 3rd prize in ‘Identification of Plants’ conducted by Friend of Trees, At VJTI, Matunga on 24th February 2008.