Summary
Overview
Work History
Education
Skills
Certification
Professional Achievements
Timeline
Generic

Swati Maithani

Aachen

Summary

Enthusiastic working professional eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow and excel in the Biobanking field.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Team Leader

Innovate Research Pvt. Ltd.
Noida
01.2020 - 01.2023
  • Conducted training and mentored team members to promote productivity and commitment to friendly service.
  • Built strong relationships with customers through positive attitude and attentive response.
  • Established open and professional relationships with team members to achieve quick resolutions for various issues.
  • Mentored and guided employees to foster proper completion of assigned duties.
  • Supervised team members to confirm compliance with set procedures and quality requirements.
  • Worked with team to identify areas of improvement and devised solutions based on findings.
  • Held weekly team meetings to inform team members on company news and updates.
  • Managed leave requests and absences and arranged covers to facilitate smooth flow of operations.
  • Oversee and manage the complete lifecycle of biospecimens collected for development in clinical studies with minimal supervision.
  • Core Clinical Team member responsible for providing Biospecimen shipping/sample movement and management including requests, query, and inventory reports, follow up active issues with vendors, review/prepare tracking activities (such as vendor manifests/inventories, etc.).
  • Responsible for independently reviewing clinical study protocol providing comparison of vendor/Client statement of work and biospecimen relevant sections and feedback with support as needed.
  • Performing routine vendor/Client management responsibilities. To request and/or access necessary vendor/system inventory files to support specimen tracking.
  • Exercised judgement within policy and procedure boundaries. To troubleshoots routine problems and prioritizing activities during critical deadlines.
  • Maintain intermediate working knowledge of study related to biospecimen requirements.
  • Ensure completion of individual Study and verification of the relevant data before handing out to the Client/Customer.
  • To create new business leads in Biospecimen Vertical.

Senior Clinical Research Associate

Innovate Research Pvt. Ltd.
Noida
01.2019 - 01.2020
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Achieved project objectives by troubleshooting experiments and testing practical and creative solutions.
  • Conducted Site selection, initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Organize investigator’s start-up meeting and study site initiation meetings.
  • Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
  • Participate in global conference calls and meetings to review progress of ongoing clinical trials.
  • Manage the Contract Research Organizations – initial identification of a suitable partner, communication plan, divisions of responsibility, milestones, contract with CRO, review monthly status reports, and the interactive management of CRO to ensure project success.

Clinical Research Associate

Innovate Research Pvt. Ltd.
Noida
08.2018 - 01.2019
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Created and maintained database and records filing system to document data on specimen collection, processing and storage.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Organized and maintained research study regulatory documents in Trial Master File to maintain accuracy and integrity.

Clinical Research Coordinator

Manipal University
Mangalore
04.2016 - 07.2017
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Followed informed consent processes and maintained records.
  • Gathered, processed, and shipped lab specimens.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Monitored patient safety throughout clinical trials and reported any adverse events.

Education

Master of Pharmacy - Pharmacology

Rajiv Gandhi University Health Sciences
Bangalore, India
03.2015

Bachelor of Pharmacy - Pharmacy

Uttarakhand Technical University
Dehradun, India
11.2012

Skills

  • SOP Writing
  • Microsoft Office with Strong MS Excel Abilities
  • Flexible and Adaptable
  • Organization and Time management
  • Ability to Work Independently and also in a Team
  • Problem Solving/Troubleshooting
  • Detail Oriented
  • Clinical/Clinical Trial & Operations Support
  • Interpersonal Strengths
  • Strong Verbal and Written Communication
  • Confident and Quick Learner
  • Multitasking

Certification

  • Successfully completed Essentials of Biobanking Course from ISBER, International Society for Biological and environmental repositories.
  • Participated in “Biobanking International Symposium” organized by National Liver Disease Biobank at the Institute of Liver and Biliary Sciences, New Delhi on 20th & 21st February, 2020.
  • Participated in virtual “Biobanking International Symposium” organized by National Liver Disease Biobank & Biobank India Foundation 21st February, 2022.


Professional Achievements

  

1. Awarded “Letter of Recognition” for exceptional contribution at Innovate Research Pvt. Ltd. In year 2021

2. Received “Certificate of Appreciation for Hardwork” at Innovate Research Pvt. Ltd in year 2022

3. Received “Service Excellence Award” at Innovate Research Pvt. Ltd in year 2022

Timeline

Team Leader

Innovate Research Pvt. Ltd.
01.2020 - 01.2023

Senior Clinical Research Associate

Innovate Research Pvt. Ltd.
01.2019 - 01.2020

Clinical Research Associate

Innovate Research Pvt. Ltd.
08.2018 - 01.2019

Clinical Research Coordinator

Manipal University
04.2016 - 07.2017

Master of Pharmacy - Pharmacology

Rajiv Gandhi University Health Sciences

Bachelor of Pharmacy - Pharmacy

Uttarakhand Technical University

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