Summary
Overview
Work History
Education
Skills
Certification
Additional Information
Timeline
Generic

Aswitha Balaji

Melbourne,VIC

Summary

High-performing Clinical Trials coordinator, with 3 years of CRO experience, seeking leadership and management roles. Well-rounded and passionate healthcare professional with strong project management and interpersonal skills.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Clinical Trials Coordinator

Alfred Health
12.2022 - Current
  • - Independently manages a Phase III clinical trial strictly in line with Monash University / Alfred Health HREC approved protocols, NHMRC and ICH-GCP guidelines and Alfred Health Standard Operation Procedures (SOP)
  • - Achieves trial milestones by creating study schedules and trial procedures hand-in-hand with Principal Investigator. coordinates with multiple functional departments to organise, perform and report study visits.
  • - Recruited 5+ participants and performs in-person and digital participant and database management with minimal supervision
  • - Liaises with external and internal stakeholders (CROs) to organise Monitoring visits and regular safety/sponsor meetings.
  • -Prepares and manages all trial related regulatory documents and manages Investigator site files, study equipment registries and ECANs/ICANs.
  • - Reports SAEs/SUSARs/AEs as per CTCAE and strictly oversees participant safety and oversees quality assurance of study specific equipment
  • - Performs phone visits, data entry and organises pathology collections for a Phase IV Australia-wide clinical trial.
  • -Prepares classified Biological samples and organises their International shipments, strictly in line with IATA certification requirements.
  • -Performs trial-related Clinical /diagnostic procedures such as Administration of Investigational Products, Venepunctures, Vital signs assessments, ECGs and other study-specific procedures on Clinical trial subjects.

Clinical Trials Coordinator

Nucleus Network
02.2021 - 10.2022
  • Managed and executed multiple full-fledged FIH Phase I clinical trial studies, strictly in line with HREC approved protocols, ICH-GCP guidelines and Nucleus Network Standard Operation Procedures (SOP)
  • Created and managed Clinical Taskpads, Source documents, regulatory documents and Investigator site files.
  • Performed trial-related Clinical procedures such as Administration of Investigational Products, Venepunctures, Intravenous dwelling via Cannulations, Vital signs assessments, ECGs and other study-specific procedures on Clinical trial subjects. Frontline worker throughout COVID-19 pandemic lockdowns.
  • Trained in SUSAR/SAE reporting, CTCAE based Adverse event management and conducted Safety Data Review Summary meetings between Sponsor Medical Monitors, Principal investigators and Internal functional departments.
  • Managed various Administrative tasks, Data Transcription and Management from SFSD to Clinical eCRF databases, Subject Tracking logs and Digital diaries of participants, and providing CRO-verified and accurate data to Sponsors.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies, following Informed Consent process

Market Research Analyst

Agilent Technologies
02.2020 - 11.2020
  • Collected and analyzed data on customer demographics, preferences, needs and buying habits to identify potential markets and factors affecting product demand. Gathered data on competitors to analyze prices, sales and methods of marketing and distribution.
  • Spearheaded a team of five and was the main point of contact between stakeholders and clients whilst primarily handling remote work and Navigating stage-3 lockdown restrictions.
  • Developed efficient commercialization strategies for Market-entry
  • Created and presented real-time reports on current market conditions to upper management.

Clinical Trials Assistant

The University of Melbourne
10.2019 - 12.2019
  • Assistant to the Primary coordinator of In-field Sheep clinical trials, traveled to Dookie for 3 months of rural research
  • Created a strong foundation in understanding and running Clinical trials
  • Performed various trial-related tasks and studied behavioural responses of Sheep in exposure to various external stressors and the relationship between optimal wool quality and stress levels.

Education

Master of Biotechnology - Biotechnology

The University of Melbourne
Melbourne, VIC
03.2021

Bachelor of Biotechnology - Biotechnology

SASTRA University
Thanjavur, India
2018

Skills

  • High level written and oral communication in English, Tamil and Hindi, including interpretation and translation/transcription
  • Informed consent, Trial management, ICH-GCP/GDP, Clinical Protocol execution, Medication dispensing and administration
  • Software Proficiency- MS office suite, Google suite programs, Project management software, EDCs (Oracle, ExoStar, Medrio, InForm,ERT, iMedidata and Videoc, Cerner Power chart, etc)
  • Analytical and Critical Thinking
  • Solution oriented and expert Problem solver
  • Impeccable personal/professional organization, Multi-tasking and Time Management
  • Active listening and Attention to Detail
  • Efficient and thoughtful Decision-Making
  • Excellent customer service and people skills from working with diverse demographics
  • Transferable skills from previous hospitality, Tutoring and research roles
  • Strong sense of work ethic and commitment
  • Creative, driven and dedicated

Certification

IATA Safe Transport of Infectious Substances by Air (CASA.DGTNG.0194 Rev 1)

ICH Good Clinical Practice E6 (R2) (NIDA)

Working with Children Check- Obtained March 2021

A-CTEC Australian Clinical Trials certification


Additional Information

- 1.5 years of previous hospitality experience as an F&B all rounder with an RSA certification

- 2 years of Voluntary tutoring with The Smith Family and a WWCC certification

- 1 year of Private tutoring for Grade 4-6 VCE students in Math, English and Sciene

- Freelance content creator and writer with Upwork

Timeline

Clinical Trials Coordinator

Alfred Health
12.2022 - Current

Clinical Trials Coordinator

Nucleus Network
02.2021 - 10.2022

Market Research Analyst

Agilent Technologies
02.2020 - 11.2020

Clinical Trials Assistant

The University of Melbourne
10.2019 - 12.2019

Master of Biotechnology - Biotechnology

The University of Melbourne

Bachelor of Biotechnology - Biotechnology

SASTRA University

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Aswitha Balaji