Knowledgeable Clinical Research Associate with several years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.
Overview
7
7
years of professional experience
Work History
Clinical Research Associate
GenesisCare
Melbourne, VIC
03.2024 - Current
Managing Radio-as-PrecisionIO clinical trial for metastatic cancer.
Managing the Chrono-radiotherapy study for lung and melanoma cancer.
Performed clinical research activities including protocol development, subject recruitment and data collection.
Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
Developed and managed budgets for clinical trials according to study protocols.
Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
Provided support in writing informed consent forms, patient diaries, study manuals.
Conducted relevant literature searches and writing reports, presentations.
Written manuscripts for publications.
Developed clinical trial documentation for the ethics committee's examination and approval.
Clinical Research Coordinator
GenesisCare
Melbourne, VIC
12.2022 - 03.2024
Managed the AUS-PREDICT clinical trial for breast cancer and DCISionRT.
Managed ADAPT-MRL registry for radiotherapy treatment.
Managed the Theranostic (THA) trial for radioactive drug treatment and prostate cancer.
Collected participants' clinical data in EDC using the MOSAIQ Radiation Oncology Information System.
Compiled trial related documents into a master file as required by sponsor or regulatory agency.
Managed EDC systems (Prelude, CASTOR, and REDCap) for data collection.
Managed clinical trial documents, such as signed consent forms by participants and SOP.
Managed data queries and reporting for radiation oncologists.
Developed data management plans in oncology, such as coding, reporting, and workflow.
Resolved problems with databases.
· Ensured regulatory, ICH-GCP and protocol compliance.
Clinical Coder
Telstra Health Pty Ltd
Melbourne, VIC
03.2020 - 11.2020
Reviewed patient medical records and assigned appropriate codes to diagnoses and procedures according to ICD-10-CM guidelines.
Developed strategies to improve coding processes and reduce errors.
Utilized computer software programs designed specifically for coding applications, including SNOMED-CT.
Participated in interdisciplinary meetings with providers, staff, administrators., offering insight into the impact of documentation on reimbursement levels.
Maintained up-to-date knowledge of coding standards and regulations by attending seminars and reading professional journals.
Conducted periodic audits of coding activities using established criteria.
Maintained current working knowledge of CPT and ICD-10 coding principles, government regulation, protocols and third-party billing requirements.
Clinical Project Manager
Alan Walker Cancer Care Centre
Darwin, NT
02.2019 - 06.2019
Interviewed cancer patients, including Indigenous and non-Indigenous, for recruitment.
Verified that the process of obtaining informed consent has been adequately performed and documented for each subject, as required.
Maintained patient's treatment schedules.
Utilized MOSAIQ® system for collecting clinical data of prostate cancer patients.
Managed Indigenous Australian follow-up appointments for further assessment.
Collected post-radiotherapy outcomes of prostate cancer patients.
Coordinated patient travel plans for Indigenous Australian cancer patients.
Post-treatment follow-up and review of the side effects of radiotherapy.
Associated with NT rural clinics and prepared charts for Australian Indigenous cancer patients' prospective treatment schedules.
Research Assistant
University of Tasmania
Launceston , TAS
12.2017 - 06.2018
Supported and searched the scientific literature for the lung cancer project.
Prepared histologic slides via tissue sectioning, immunohistochemical (IHC) staining, and mounting.
Assessed suitability of chemicals and stains.
Evaluated and optimized primary antibodies for IHC staining.
Supported microscopic examination with the help of the project manager.
Structured manuscripts for publication related to the lung cancer project.
Organized and analyzed qualitative and quantitative data using statistical software packages such as SPSS or STATA.
Assisted in the design and implementation of experimental protocols.
Monitored progress of projects to ensure timely completion within budget constraints.
Collaborated with other researchers in developing study designs, methods, and tools for data collection.
Education
Ph.D. - Translation Radiation Oncology And Prostate Cancer
Charles Darwin University
Darwin, NT
10-2019
Master By Research - Head And Neck Cancer
Charles Darwin University
Darwin, NT
07-2013
Master of Science - Molecular Biology And Biochemistry
Guru Nanak Dev University
Amritsar
07-2005
Bachelor of Science - Biological Science
Guru Nanak Dev University
Amritsar
07-2001
Skills
Protocol adherence
Study design
Protocols development
Research and Development
Patient recruitment
Data Evaluation
Site monitoring
Good clinical practice
Data Collection
Report Writing
Clinical Documentation
Project Management
Publications
Expression of microRNAs following radiation therapy and association with severity of radiotherapy‑induced toxicity among patients with prostate adenocarcinoma: A systematic review and meta‑analysis.
Singh J, Thachil T, Eapen MS, Lim A, Sufyan W, Rawson R, Duncan H, De Ieso P and Sohal SS: Immunohistochemical investigation of cytokine expression levels as biomarkers in transrectal ultrasound‑guided needle biopsy specimens of prostate adenocarcinoma. Mol Clin Oncol 15: 191, 2021.
Singh, J., Sohal, SS., Ahuja, K., Lim, A., Duncan, H., Thachil, T., De Ieso, P. Investigation of circulatory cytokines in patients undergoing intensity-modulated radiotherapy (IMRT) for adenocarcinoma of the prostate and association with acute RT-induced toxicity: A prospective clinical study. Cytokines 2020. https://doi.org/10.1016/j.cyto.2020.155108.
Singh J, Sohal SS, Ahuja K, Lim A, Duncan H, Thachil T, De Ieso P. Levels of plasma cytokine in patients undergoing neoadjuvant androgen deprivation therapy and external beam radiation therapy for adenocarcinoma of the prostate. Ann Transl Med 2020. doi: 10.21037/atm-19-1913.
Singh, J., Sohal, SS., Lim, A., Duncan, H., Thachil, T., De Ieso, P. Cytokines expression levels from tissue, plasma, or serum as promising clinical biomarkers in adenocarcinoma of the prostate: a systematic review of recent findings. Ann Transl Med 2019. doi: 10.21037/atm.2019.05.31.
Singh, J., Jayaraj, R., Baxi, S., Mileva, M., Skinner, J., Dhand, N.S., Thomas, M. Immunohistochemical expression of p53 and eIF4E markers in histologically negative surgical margins and association with clinical outcome of head and neck squamous cell carcinoma (HNSCC) patients. Molecular and Clinical Oncology. DOI: 10.3892/mco.2015.689.
Singh, J., Jayaraj, R., Baxi, S., Ramamoorthi, R., Thomas, T. The risk factors of head and neck cancer and their general patterns in Australia: a descriptive review and update. Journal of Environmental Pathology, Toxicology and Oncology. 2014; Volume 33.
Jayaraj, R., Singh, J., Baxi, S., Ramamoorthi, R., Thomas, T. Trends in Incidence of Head and Neck Cancer in the Northern Territory, Australia, between 2007 and 2010. Asian Pacific Journal of Cancer Prevention. 2014; 15(18):7753-6.
Singh, J., Jayaraj, R., Baxi, S., Ramamoorthi, R., Thomas, T. Incidence and mortality from mucosal head and neck cancers amongst Australian States and Territories – what it means for the Northern Territory. Asian Pacific Journal of Cancer Prevention. 2013; Volume 14.
Singh, J., Jayaraj, R., Baxi, S., Curtin, J., Thomas, T. An Australian retrospective study to evaluate the prognostic role of p53 and eIF4E cancer markers in patients with head and neck squamous cell carcinoma (HNSCC): study protocol. Asian Pacific Journal of Cancer Prevention. 2013; Volume.
Thomas, M., Singh, J., Lys, I., Car, G., Mileva, M., Baxi, S. Identification of molecular and immuno-diagnostic cancer markers in northern territory Australian Indigenous population. Oral oncology 2011; 47, Supplement 1(0): S96.
Thomas, M., Singh, J., Jayaraj, R. Head and Neck malignancy in Northern Territory. The Internet Journal of Head and Neck Surgery. 2011 Volume 4 Number 2.
Professional Membership
Clinical Research Education Workshop (CREW)
Prostate Cancer Foundation of Australia
Clinical Oncology Society of Australia (COSA)
Prostate Cancer Collaborative Research Alliance
Trans-Tasman Radiation Oncology Group (TROG) Cancer Research
Media Exposure
Interviewed by SBS Radio (based in Australia) to provide the output concerning prostate cancer research in the Northern Territory and cancer research opportunities at Charles Darwin University, 2018 (ttps://www.sbs.com.au/language/english/sikh-scientist-is-the-face-of-diversity-in-leading-australian-university)
References
References available upon request.
Timeline
Clinical Research Associate
GenesisCare
03.2024 - Current
Clinical Research Coordinator
GenesisCare
12.2022 - 03.2024
Clinical Coder
Telstra Health Pty Ltd
03.2020 - 11.2020
Clinical Project Manager
Alan Walker Cancer Care Centre
02.2019 - 06.2019
Research Assistant
University of Tasmania
12.2017 - 06.2018
Ph.D. - Translation Radiation Oncology And Prostate Cancer
Charles Darwin University
Master By Research - Head And Neck Cancer
Charles Darwin University
Master of Science - Molecular Biology And Biochemistry
Guru Nanak Dev University
Bachelor of Science - Biological Science
Guru Nanak Dev University
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