Sonya Singh
Cranbourne West
Summary
Hardworking and reliable Senior Clinical Research Associate with 6.5 years experience in independent monitoring specializing in Oncology/Haematology Clinical Trials. I take pride in completing all tasks with high quality and can adapt well under pressure. I am both a team player and a strong individual worker when required, forming strong relationships with my sites, co-workers and Sponsors.
Overview
13
13
years of professional experience
Work History
Sr CRA II
Syneos Health
06.2025 - Current
- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, including all study documentation (ISF/TMF completeness and reconciliation) . Site management activities include all in-house and on-site monitoring for all visit types
- Mentor and Train Junior Level CRAs
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM and RCPM.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Maintains a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes; completes and adheres to assigned training as required
Sr CRA I
Syneos Health
05.2022 - 06.2025
- Responsible for monitoring all types of clinical trials; assures site/investigator adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
- Primary responsibility is for site management and performance, including all study documentation (ISF/TMF completeness and reconciliation). Site management activities include all in-house and on-site monitoring for all visit types.
- Maintains a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes; completes and adheres to assigned training as required
- May mentor and train junior-level CRAs
- Responsible for collaboration with Central Monitors assigned to clinical research projects for which in-house centralized monitoring activities occur.
CRA II
Syneos Health
08.2020 - 04.2022
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, subject retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per CRA Escalation Pathway as appropriate in collaboration with CRA Manager.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Clinical Research Associate I
Medpace Australia
12.2018 - 08.2020
- Conduct site qualification, initiation, monitoring, and close-out visits according to ICH-GCP, Medpace/Sponsor SOPs, and applicable regulatory requirements
- Responsible for overall site management for assigned sites, including written and verbal communication and scheduling of monitoring visits
- Responsible for completion of visit reports, follow up letters, and maintenance of study-related databases
- Experience in monitoring oncology and cardiovascular clinical trials.
- Office Based
Clinical Trial Assistant (Intern)
Medpace Australia
02.2018 - 11.2018
- Clinical Research Associate support updating trackers, preparing for site visits, attending site monitoring visits
- Project Coordinator support - providing study supplies to sites including site binders, patient items, equipment
- Regulatory Submissions support pre-populating essential documents, PEDP Submission, Compliance checks, CTN Application
- Feasibility assessing sites for a new trial, maintain strong/polite communication to ensure sites complete the feasibility, exceeding the number of sites expected for the study.
- General Administration printing, filing, shipping, invoicing, reception coverage.
Pharmacy Assistant
Chemist Warehouse
11.2012 - 01.2018
- Counselling patients on medications depending on symptoms
- Receiving and handing out prescriptions in the dispensary under pharmacist supervision
- Developing skills in resolving conflict - customer and team member related
- Restocking and counting stock on shelves
- Training new team members
Education
Bachelor - Pharmaceutical Sciences (Hons)
Royal Melbourne Institute of Technology (RMIT)
01.2018
Bachelor - Pharmaceutical Sciences
Royal Melbourne Institute of Technology (RMIT)
01.2017
Skills
- Effective Time management
- Attention to detail
- Flexible and adaptable
- Critical thinking
- Proficiency in Microsoft Office
- Strong Organizational skills
- Teamwork and collaboration
- Extensive knowledge of CTMS, EDC, IRT, TMF systems
- Extensive knowledge of GCP guidelines, CRO/Sponsor SOPs
THERAPEUTIC EXPERIENCE
- Cardiovascular: Ischaemic heart disease, Coronary Syndrome, Acute
- Dermatology: Eczema/Dermatitis
- Endocrinology/Metabolism: Lysosomal storage disorders, Pompe's disease
- Haematology: Bleeding disorders, Haemophilia A
- Nephrology: Kidney diseases, IgA nephropathy
- Oncology: Multiple myeloma, Non-Hodgkin lymphoma (NHL)
- Oncology: Non-small cell lung cancer (NSCLC)
- Respiratory: Chronic obstructive airways disease, Asthma
Timeline
Sr CRA II
Syneos Health
06.2025 - Current
Sr CRA I
Syneos Health
05.2022 - 06.2025
CRA II
Syneos Health
08.2020 - 04.2022
Clinical Research Associate I
Medpace Australia
12.2018 - 08.2020
Clinical Trial Assistant (Intern)
Medpace Australia
02.2018 - 11.2018
Pharmacy Assistant
Chemist Warehouse
11.2012 - 01.2018
Bachelor - Pharmaceutical Sciences (Hons)
Royal Melbourne Institute of Technology (RMIT)
Bachelor - Pharmaceutical Sciences
Royal Melbourne Institute of Technology (RMIT)
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