Namrata Raju S.R.
Bengaluru
Summary
Seeking a career enhancement with 5 years of work experience in World Clinical Research Organization (IQVIA-Formerly Quintiles) and facilitated more than 700 sites as "Site Start up Specialist" in study Start up Activities such as preparation of ICF as per Country regulations and Sponsor requirements, review and Approval of Essential documents which help in IP release. Gained experience in working in progressive and challenging environment with a strong eye for detail and good knowledge of ICH – GCP guidelines. Provide project related assistance for assigned complex projet(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Site Start-Up Specialist
QUINTILES IMS (INDIA) PVT LTD
- Global Quality check person for review of document for its completeness, consistency and accuracy with quality for the deliverables to the customers. Ensuring the quality of the outcome meets the established standards
- Oversight of the team deliverables.
- SPOC for EDP Related process, training and mentoring new joiners.
- RESPONSIBILITIES:
Study Start Up Associate – 1
ICON Clinical Research pvt ltd
03.2021 - Current
- Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial.
- Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.
- This includes, but it is not limited to:
- EC approvals for trial amendments.
- EC notifications.
- Responsible for the timely follow-up for queries made by EC’s.
- Anticipated activities may include attendance at Kick-Off, Investigator or study team meetings.
- Attending study meetings with internal &/ or external stakeholders in maintenance phase of the study by providing country specific expertise to study start up leads and project teams
- Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the Sponsor and Informed consent team.
- Responsible for the co-ordination of translation documents required for IRB/IEC submissions.
- Date of Employment : 03/2021 - till date
- Job Tittle: Study Start Up Associate – 1
- Business Tittle: Study Start Up Associate – 1
Site Start-Up Specialist
IQVIA (Quintiles)
10.2018 - 12.2019
- Perform assigned complex administrative tasks to support team members with project execution
- Date of Employment: 10/2018 – 12/2019
- Job Title: Site Start-Up Specialist
- Business Title: Site Start-Up Specialist
Reg & Start Up Spec1(c RSU)
IQVIA (Quintiles)
09.2017 - 10.2018
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Participate in document management (creation, review, maintenance, storage, as applicable)
- I am also working as an Allocator for North America Cluster and involved in Task creation for EDP services, ELVIS Contract upload an Site ID promotion process. Also assigning tasks to the team member and checking for SLA Compliance. Also clarifies doubt of the resource.
- Working as RSU-WF Business Champion, Establish and maintain effective project/ site communications
- Date of Employment: 09/2017 - 10/2018
- Job Title: Reg & Start Up Spec1(c RSU)
- Business Title: Reg & Start Up Spec1(c RSU)
Sr. Clinical Process Associate
IQVIA (Quintiles)
10.2016 - 09.2017
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Participate in document management (creation, review, maintenance, storage, as applicable)
- I am also working as an Allocator for North America Cluster and involved in Task creation for EDP services, ELVIS Contract upload an Site ID promotion process. Also assigning tasks to the team member and checking for SLA Compliance. Also clarifies doubt of the resource
- Date of Employment: 10/2016 - 09/2017
- Job Title: Sr. Clinical Process Associate
- Business Title: Sr. Clinical Process Associate
Clinical Process Associate -2
IQVIA (Quintiles)
10.2015 - 10.2016
- Perform assigned complex administrative tasks to support team members with project execution
- Assist in updating and maintaining complex data in systems within project timelines and per project plans
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents
- Ensure accurate completion and maintenance of internal systems
- Date of Employment: 10/2015 - 10/2016
- Job Title: Clinical Process Associate -2
- Business Title: Clinical Process Associate -2
Clinical Process Associate -1
IQVIA (Quintiles)
04.2015 - 10.2015
- Complete appropriate role-specific training to perform job duties
- Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.)
- Assist in updating and maintaining systems within project timelines and per project plans
- Date of Employment: 04/2015 - 10/2015
- Job Title: Clinical Process Associate -1
- Business Title: Clinical Process Associate -1
ISS Coordinator
IQVIA (Quintiles)
10.2014 - 04.2015
- Assist the team in the preparation, handling, distribution, filing and archiving of documentation according to the scope of work and standard operating procedures.
- Review documents for completeness, consistency and accuracy, under guidance of senior staff.
- Prepare client deliverable documents using appropriate tools and may draft text for straightforward documents, under guidance of senior staff.
- Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans with project specific information
- Interact with internal and external clients, under guidance of senior staff.
- May perform IP release activities on small, straightforward projects or support reviews for larger projects
- Date of Employment: 10/2014 - 04/2015
- Job Title: ISS Coordinator
- Business Title: ISS Coordinator
Education
M. Sc - Microbiology
M S Ramaiah College of Arts, Science & Commerce
06.2013
B. Sc - Genetics
M S Ramaiah College of Arts, Science & Commerce
07.2011
Skills
- Self Confidence
- Adaptable
- Optimistic
- Multi-tasking
Certification
- Certificate on GCP principle exam- Barnette Accreditation-GCP 2015, Exam cleared on 15Jun2015
- Fundamentals on GCP Accreditation Exam - Barnette Accreditation-GCP 2016, Exam cleared on 01Nov 2016
- Fundamentals on GCP Accreditation Exam - Barnette Accreditation-GCP 2018, Exam cleared on 23rd June 2018
Language(s)
Hindi: Speaking Fluent, Reading Fluent, Writing Fluent
English: Speaking Fluent, Reading Fluent, Writing Fluent
Kannada: Speaking Fluent, Reading Fluent, Writing Basic
Telugu: Speaking Fluent, Reading Fluent, Writing Basic
Timeline
Study Start Up Associate – 1
ICON Clinical Research pvt ltd
03.2021 - Current
Site Start-Up Specialist
IQVIA (Quintiles)
10.2018 - 12.2019
Reg & Start Up Spec1(c RSU)
IQVIA (Quintiles)
09.2017 - 10.2018
Sr. Clinical Process Associate
IQVIA (Quintiles)
10.2016 - 09.2017
Clinical Process Associate -2
IQVIA (Quintiles)
10.2015 - 10.2016
Clinical Process Associate -1
IQVIA (Quintiles)
04.2015 - 10.2015
ISS Coordinator
IQVIA (Quintiles)
10.2014 - 04.2015
Site Start-Up Specialist
QUINTILES IMS (INDIA) PVT LTD
M. Sc - Microbiology
M S Ramaiah College of Arts, Science & Commerce
B. Sc - Genetics
M S Ramaiah College of Arts, Science & Commerce
CONTACTS & ACCOUNTS MANAGEMENT
Create uniformed entry into CTMS that will provide our monitors overall objectives for study success. Creation, Updating & promotion of Investigators in CTMS.
SPONSOR SPECIFIC REVIEW: GILEAD
- Involved in reviewing Sponsor specific Regulatory package & QC.
- LEC/CEC Approvals, meeting type, clinical trial agreements, Investigator brochure , Protocol, FDA 1572, Investigator and sub investigator CV, their experience, previous clinical trial experience, licenses to practice it, affiliation with the trial sites, GCP trainings and accreditation and regulatory approvals, ICF checking, review of subject materials, FDF, EU FDF, import license, export license, central labs, local labs certifications, lab ranges and cv of lab directors based on country requirements as well as sponsor requirements, based on verification planning site initiation, start up, holding or releasing IP to sites.
- Sending the reviewed checklist to sponsor directly, sponsor reverts back, if any changes required as per their requirement. If need by, re-reviewing is made and resent for Site Initiation.
MIDSTREAM
Supporting NA (US & Canada) Regulatory Start up (RSU) with the Uploading of EDP in RSU Workflow that was approved prior RSU Workflow system launch, which is in Pilot stage.
Extra activities
Part of Clinical Development program and had a chance to visit Onsite Monitoring visit along with CRA.
PROCESS DETAILS
- Submission & Approval Tracking:
- Creating templates based on Country IP release requirements & tracking of documents:
- Tracking of EC and RA Submissions in CTMS.
- Tracking of Submission & Approval documents under Core, Country & Site level such as IMP Information, Patient materials, milestones for monitoring purpose.
- Submission & Approval of amendments to EC’s based on sponsor request.
- Reviews of Essential Documents:
- Review and management of IP pack (regulatory green light) documents essential for site SIV.
- Verification/Review of clinical trial essential documents like:
- IRB/IEC approvals, LEC/CEC Approvals, GCP compliance statement, composition of bodies, meeting type, clinical trial agreements, Investigator brochure , Protocol, FDA 1572, Investigator and sub investigator CV, their experience, previous clinical trial experience, licenses to practice it, affiliation with the trial sites, GCP trainings and accreditation and regulatory approvals, ICF checking, review of subject materials, FDF, EU FDF, import license, export license, central labs, local labs certifications, lab ranges and cv of lab directors based on country requirements as well as sponsor requirements, based on verification planning site initiation, start up, holding or releasing IP to sites.
- Looking after effective coordination of the IP pack review process. If required, performing expedited review of regulatory green light docs without losing quality of review.
- Awareness of various country IP release regulations and their update and simultaneously informing the customers about the changes and making sure they are not overlooked
- Clinical Trial Management System (CTMS) Database tracking:
- Assist with completion of relevant Clinical Trial Management System (CTMS) fields, databases, tracking tools, timelines and project plans with project specific information.
- Translation:
- Functioning as a primary means of communication for internal customers and third-party Vendors (Trans perfect & RRD Solutions) for queries related to site and country documents when submitted for translation.
- Labels:
- Involved in Label customization and preparation for Investigational Product for various countries based on Sponsor request.
- E TMF Filing:
- Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meeting, preparing and distributing status reports, creating and maintaining study documents, etc.)
- Accountable for the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents and TMF tracking and reporting to internal and external customers
- Ensures the TMF file structure is in compliance with applicable company approved TMF configuration, with reference to ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the DIA TMF Reference Model, as required
- Ensures customer requests for retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner
- Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, regulatory and other non-clinical documents, as assigned
- Develops and maintains company’s digital records/TMF training materials and guidelines and performs training and/or coaching of new and existing staff (for Updates) as required.
- May supervise and/or mentor less experienced Regulatory Document personnel
EXTRA CURRICULUM ACTIVITIES
Poster presentation Swimming & playing Badminton
DECLARATION
I vouch the authenticity of the above-mentioned information is true & to best of my knowledge. Place: Bengaluru Namrata Raju S.R.