Jagadish Kumar Mohanta

Experience

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  Novo Nordisk

  May 2008 - May 2010

  Clinical Research Associate

  Responsibilities as a CRA:Site feasibility, site selection, site initiation visit, conducting investigators meeting, obtaining agreements from investigators like (confidentiality, financial, protocol) before the site initiation, collection of source documents from, collection & send CRF to the Head Office, overlooking patient recruitment status, monitoring visits to the site, Clinical onsite monitoring activities (patient recruitment, source data verification, drug accountability & data Collection), report SAE and AE to Head office, Study close out visit & Resolve of Data Clarification Forms etcConducted:I have successfully completed 3 studies in Novo Nordisk in Type II diabetic patients. Achievement:I have successfully completed 3 studies in Novo Nordisk. It is multicenter; open labeled, nonrandomized, noninterventional, observational study in Type II diabetic patients. Show less

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  Max Neeman International

  May 2010 - Aug 2011

  Clinical Research Coordinator

  Responsibilities as CRC:Site of selection, conducting investigators meeting, taking agreements from investigators like (confidentiality, financial, protocol) before the site initiation, site initiation visit, collection of source documents from sites, Filling of CRFs, sending the CRFs to the Head Office, overlooking patient recruitment status, monitoring visits to the site, reporting SAE and AE to Head office, Study close out visit & Resolve of Data Clarification Forms.Conducted:I have successfully completed 3 studies in Max Neeman. Show less

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  Ranbaxy

  Aug 2011 - Jun 2015

  Sr Executive for NCE in (Clinical & Medical Affair Dept.) for Innovative Product Team

  • Responsibilities as Senior Executive (NCE): o Clinical Monitoringo Clinical Onsite Monitoring activities (drive patient recruitment, source data verification, drug accountability & data collection)o Collecting Regulatory document & Investigator Agreement (CV, confidential, financial)o Initiation, monitoring & termination of sites in accordance with ICH-GCP guidelineso Preparation of site feasibility questionnaire, conducting feasibility & report to PM.o Preparation, conduct & reporting of site selection visito Negotiation & obtaining investigator agreement on site budget, payment to the siteso Develop study specific documentso Maintenance of TMF & site specific fileo Conducting investigator meeting acting as host for the meetingo Provide Training to Investigator as well as Investigator Staffo Collecting & sending Form ( like Patient Inform Consent Form, CRF, AE/SAE Form) o Patient Screening & Enrolment; ensure protocol & regulatory complianceo Laboratory Agreements; facilitate free lab investigations for patients o KOLs identification & engagementso Undertake Disease Management & Practice Management Surveyo Resolution of queries from marketing, field force, customized PPTs for doctors• Conducted:o Managing Phase III Clinical Trial of new innovated molecules of Ranbaxyo Observational study & Phase IV of new innovated molecules of Ranbaxy.o Pre Launch Marketing o Scientific & Medical Education Programme for Health Care professionals.o Video interviews of KOLs for new innovated molecules of Ranbaxy.• Work Relationship: o Doctors/KOLs, Hospital-Paramedics, Patients, Pathologists/Laboratory assistants, Sales team & medical department.• Achievement: o Achieve 3 Appreciation Award (WOW Certificate) in RANBAXY in year 2010, 2011 & 2012 for Best Performance. Show less

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  George Clinical

  Jul 2015 - Dec 2015

  Clinical Research Associate

  • Responsibilities as CRA: o Overseeing all aspects of the clinical trial process. Ensuring trials are conducted, recorded and reported according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirementso Conduct Site Identification and conduct Feasibility Studies.o Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.o Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.o Writing pre-visit letters, follow up letters and site visit reportso Keep a close association with site for: Patient Recruitment, Patient Follow up & Protocol related activities.o Maintain accurate and timely correspondence and communication with sponsor/site.o Conduct training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.o Prepare Ethics Committee Submission Dossier.o Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File. o Source Data Verification as per the Clinical Management Plano Control investigational product accountability through physical inventory and records review. Control trial supplies ordering & dispatch of investigational product to site.o Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study. o Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc.o Facilitate effective communication between investigational sites and the project team through written, oral and electronic contactso Archival of study documents.o Good Knowledge of ICH-GCP, FDA and all applicable guidelines in conducting Clinical Trial Show less

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  IQVIA

  Dec 2015 - Aug 2018

  Clinical Process Specilalist

   Overseeing all aspects of the clinical trial process. Ensuring trials are conducted, recorded and reported according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements Manage a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review assigned visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs. Provide guidance to the CPM at project start-up and throughout the study, in development of visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs: Assist CPMs in the utilization of the standard annotations to limit unnecessary customization. Collaborate with CPMs on training of SVR annotations, completion and submission per SOP. Identify and track the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA and/or if necessary their Line Manager. Prepare and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CPMs and CRA LM and/or Clinical Site Monitoring Quality Manager (CSiMQM), as necessary. Review the visit reports to ensure identification and implementation of findings or focused site visit observations requiring corrective and /or preventative action plans. Attend regular teleconferences with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CPMs with review of the trends emerging from the Issue Escalation Log.Achievements: Received WWD (Work Worth Doing)-Bravo awards from Clinical Lead and appreciation email from CRA’s. Approved >2500 Reports till date. Show less

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  IQVIA Asia Pacific

  Aug 2018 - Jan 2019

  Clinical Systems Speacilist 2

   Overseeing all aspects of the clinical trial process. Ensuring trials are conducted, recorded and reported according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements Manage a caseload of visit report reviews for assigned studies, ensuring compliance to the protocol, processes, timelines, Quintiles/applicable SOPs, and GCP guidelines. Review assigned visit reports in order to ensure all site issues are adequately documented, reported and followed up to resolution, as well as, assuring a high quality of SVRs. Provide guidance to the CPM at project start-up and throughout the study, in development of visit report annotations, guidelines, and assure efficient completion of visit reports by the CRAs: Assist CPMs in the utilization of the standard annotations to limit unnecessary customization. Collaborate with CPMs on training of SVR annotations, completion and submission per SOP. Identify and track the project team compliance to SOPs for submission and approval of the visit report through direct communication with the CRA and/or if necessary their Line Manager. Prepare and escalate issues noted in the site visit report which could impact subject safety, regulatory compliance and/or data integrity to the CPMs and CRA LM and/or Clinical Site Monitoring Quality Manager (CSiMQM), as necessary. Review the visit reports to ensure identification and implementation of findings or focused site visit observations requiring corrective and /or preventative action plans. Attend regular teleconferences with CPMs to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs in a given project. Assist the CPMs with review of the trends emerging from the Issue Escalation Log.Achievements: Received WWD (Work Worth Doing)-Bravo awards from Clinical Lead and appreciation email from CRA’s. Approved >4500 Reports till date. Show less

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  PPD

  Jan 2019 - Jun 2022

  • Central Review Manager

    Sept 2019 - Jun 2022

  • Sr RSM

    Jan 2019 - Sept 2019
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  Labcorp

  Jun 2022 - Sept 2023

  Senior Trip Reporter Reviewer
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  Fortrea

  Sept 2023 - now

  Centralized Clinical Team Lead-II