KRISHNAIAH CHAPPIDI

Experience

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  Krishna Institute of Medical Sciences (KIMS) Hyderabad - India

  May 2007 - Oct 2009

  Clinical Research Coordinator

  • Learned protocol and coordinate how study will be conducted at the site Ensure adherence to the protocol and document breaches or violations with sponsor and IRB.• Completed all regulatory and IRB submissions & Ensure initial and continued IRB review and approval.• Assisted in the process of IVRS• Patients Recruitment & Retention• Assisted in the process of administering the informed consent to potential patients and discussing in detail the patient information sheet• Follow up with site team for timely completion of the Source Documents and ensuring that all the relevant information required in the Case Record Form are present in the source document.• Collected the Whole data for every Study subject and protecting in Cupboards, Computer.• Completed the Case Record Forms within the timelines and with minimal errors• Scheduled subject visits as per the protocol to ensure maximal subject compliance retention• Coordinated all lab related activities – shipment of samples through the designated courier and ensure timely receipt of the lab reports• Compiled and updated the Trial Master File• Maintained the study related logs – screening, enrolment, drug administration, temperature and other communication logs.• Prepared the Site for Site Monitoring Visit and Site Closeout Visits• Make together the Sub Investigators for Study Related Meetings such as Audio and Video Conferences, Site Initiation Visits.• Assisted the ICH GCP Classes for Study Delegates Show less

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  George Clinical

  Nov 2009 - Jan 2015

  • Responsible for Site Feasibility, Site Selection Process, Site Initiation and Site Closeout.• Look after, conduct Monitoring at Investigator Sites and generate site monitoring visit reports.• Update project management team, client on site study status and send weekly reports.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Country Manager and work on resolution plan (CAPA). • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Update of CTMS and e-TMF • Risk based monitoring/Remote monitoring.• Help Investigator and Study Coordinators for submission of Essential documents to Ethics Committee.• Maintain the Study Documents and Management of Clinical Trial Supplies.• Ensure that Site should conduct study according to Protocol, compliant with ICH-GCP guidelines and regulatory norms.• Coordinate for arrangements of CRAs and Investigator’s Meetings. Coordinate for Endpoint Adjudication and Serious Adverse Event (SAE) reporting. • Prepare project management reports for clients and project management team.• Mentor junior CRAs on monitoring, internal procedures, and issue escalation. Coordinate for Study payments. Show less • Responsible for Site Feasibility, Site Selection Process, Site Initiation and Site Closeout.• Look after, conduct Monitoring at Investigator Sites and generate site monitoring visit reports.• Update project management team, client on site study status and send weekly reports.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Update of CTMS and e-TMF • Risk based monitoring/Remote monitoring.• Help Investigator and Study Coordinators for submission of Essential documents to Ethics Committee.• Maintain the Study Documents and Management of Clinical Trial Supplies.• Ensure that Site should conduct study according to Protocol, compliant with ICH-GCP guidelines and regulatory norms.• Coordinate for arrangements of CRAs and Investigator’s Meetings. Coordinate for Endpoint Adjudication and Serious Adverse Event (SAE) reporting. • Prepare project management reports for clients and project management team.• Mentor junior CRAs on monitoring, internal procedures, and issue escalation. Coordinate for Study payments. Show less

  • Clinical Research Associate

    May 2014 - Jan 2015

  • Clinical Trial Assistant

    Nov 2009 - Apr 2014
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  Virchow Biotech Pvt Ltd - India

  Feb 2015 - now

  • Being a partner in protocol and IB design team• Writing Project and Monitoring plan.• Preparing Monitoring tools• Leading the site monitoring team.• Critical partner of clinical study management and data management groups• Conduct study level kick off meetings• Responsible for remote monitoring global clinical trials. • To review patient data for consistency, plausibility and completeness using on-line data sources.• To Identification of potential risks, safety and/or quality issues, trend analysis and trigger required follow-up actions. • To ensure high quality and complete data is available.• To conduct study start-up activities.• Conduct training for new colleagues on tools, protocol etc.• Conduct meetings, communications with different countries. Show less • Supervise/In charge/ APM for BA/BE, Pahse III and Phase 1V Studies• Excellent knowledge of ICH GCP. • Responsible for overseeing projects starting from the setup phase until the closure of a trial.• Integrating necessary elements, tools and resources to meet project requirements as per sponsor guidelines. • Investigator Contracting and Payments, Manage Clinical Resource Allocation• Creates standards and guidelines for clinical operation and programs. • Ensures adherence to SOPs, Good Clinical Practice, sponsor and EC guidelines. Guide and pro active projects, remain sensitive to available resources, compliance and therapeutic nuances. • Assess formal clinical trials, including documentation and recommendations. • Track and analyze patient resource utilization to increase efficiency and compliance.• Manage clinical operations, including day-to-day tasks, pre plans and business activities. • Direct budget, reports, and quality of operation. • Site feasibility, review and selection. • SIV(On site, telephonic),SMV sites across India.SCV activities Safety and Efficacy assessment • Assist Medical and regulatory affairs team Assist scientists in the preparation Protocol, Informed Consent Form (ICF), case report form (CRF)• Coordinate with Investigators for submitting the study related documents to IEC. Coordinate with site team for subject recruitment, screening and retention. Monitor the study and ensure to conduct as per approved protocol, ICH-GCP and on house standard operating procedure. (SOP). • Generation and maintenance of essential documents preparing to study. Report all the site visits to higher team with detailed documentation.• Coordinate with CRO * Vendors, conduct necessary inspection visits to ensure the quality. • Assist Medical affairs team for the preparation of Regulatory notifications and Applications. • eCRF and IVRS• Coordinate with CROs for Subject visits/Sample collections/Regulatory/EC Submissions/Safety reports. Show less

  • Sr.Exeutive-Clinical trials

    Jun 2016 - now

  • Executive-Clinical trials

    Feb 2015 - May 2016