Darshini Kala

Experience

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  Zydus Cadila

  Feb 2008 - May 2008

  Trainee

  I was trainee at Zydus Cadila.I observe tablet manufacturing facility,Hard gelatin and Soft Gelatin capsule preparation,Parenteral department and all other aspects of production.

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  Cadila Pharmaceuticals

  Jan 2012 - Mar 2012

  Project trainee

  - Learning organizational flow of clinical study activities- Help in Screening and recruitment volunteers, Check-in procedures as well as all study-related activities

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  SATELLITE ORTHOPAEDIC HOSPITAL AND RESEARCH CENTRE PRIVATE LIMITED

  Apr 2012 - Apr 2013

  Clinical research co-ordinator

  - Handled phase-3 global clinical trials on site- Assist the Principal Investigator for the clinical study activities - Site initiation activities and training of site-staff- Communicate with patients for their study visits and resolve their queries- Write source document, Filling e-CRFs/ paper CRFs, Maintain signed ICFs, patient files, laboratory reports and site master file- Ethics submissions and related communications- Using IWRS and IVRS for study drug dispensing, maintain Investigational product accountability and storage conditions- Communicating with pathological laboratories, X-ray facilities, and other external laboratories for co- ordinating the study visits- Assist clinical study monitors during the audits and resolve monitor's queries Show less

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  Cliantha Research Limited

  Jun 2013 - Jan 2016

  Clinical Quality Assurance Specialist

  • Audit GCP, regulatory, protocol and SOP compliance throughout the clinical study• Audit of different in-house study activities including informed consent presentations, Investigational product dispensing, Dosing, Blood sample collection and handling• Performs drug accountability and reconciliation audit • Verification of drug storage as per Protocol and SOP requirements• Quality review of in-house clinical study documents, protocols, clinical study reports• Perform vendor audits and system audits• Review of standard operating procedures• Logbook issuance and keep accountability of logbooks• Review calibration and validation documents and update calibration status in the records Show less

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  Alembic Pharmaceuticals Limited

  Jan 2016 - Apr 2017

  Corporate Clinical Quality Assurance

  • Sponsor oversight of clinical trials sponsored by company which includes onsite as well as off-site audits• Quality review of study documents, protocol, clinical study reports, and other regulatory documents• Maintain training record of the other departments’ employees and perform audits of training records on defined interval.• Perform Vendor and CRO qualification audits• Perform Clinical study audits including all in-process audit and source data audit• Prepare audit plans and approve monitoring plans• Maintain deviation index and keep record of all CAPAs• Prepare in-house SOPs and review of other department's SOPs • Assist with clinical affairs team for smooth conduct of the study• Assist other departments to solve regulatory queries• Maintain organizational charts and departmental organizational charts Show less

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  Pharmazone

  Feb 2018 - Dec 2018

  Clinical Research Associate
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  Lambda Therapeutic Research

  Dec 2018 - Sept 2020

  Medical writing and regulatory affairs associate

  • Write Protocols, Informed Consent forms, and other regulatory documentation (e.g., FDA forms, QIU, etc.) if required.• Conducting scientific literature searches for the purpose of acquiring scientific knowledge from external sources, for the purpose of conducting study feasibility and developing protocols• Prepare clinical research study ethics review forms and submit along with protocols, informed consent forms, other study-specific documentation and general study-related documents to the REB/IRB/IEC for review.• Correspond with the REB/IRB/IEC to coordinate timely receipt of REB/IRB/IEC decisions related to clinical research studies Show less

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  Syneos Health

  Sept 2020 - Oct 2021

  Clinical Research Scientist

  -Developing first in human clinical study protocol for different study designs such as SAD,MAD,Food effect, complex 505b(2) etc- Manage clinical study and provide scientific support to team throughout the clinical study- Health Canada CTA applications- Work closely with team to provide scientific support for clinical trial feasibility.

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  ICON Strategic Solutions

  Oct 2021 - now

  -Leading phase-2 global oncology basket study of Merck LLC ( core HQ study team member)- Study start-up, and execution stage- Protocol and any amendment implementation from HQ level,- Key responsible person for vendor system update and communication i.e., IVRS, Central Imaging, Central cardiac monitoring, Central lab, EDC- Main point of contact for each country manager (21 countries,110 sites)- Responsible to identify any risk, issue which can affect study milestones, operations and any other deliverables. - Mitigate identified risks and escalate it to management as needed.- Responsible to make sure each site receives their required vendor and clinical supplies on-time. Show less

  • Senior Project Manager

    Jan 2023 - now

  • Project Manager-1

    Oct 2021 - Jan 2023