Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Scientific communications
Timeline
Generic

Nethme Wickramarathne

Beaumont,Texas

Summary

As a versatile clinical research professional, I possess extensive knowledge and expertise in effectively coordinating all aspects of clinical trials. I am adept at managing patient information, laboratory samples, and compliance documents with precision and attention to detail. With a strong organizational acumen, I consistently ensure seamless processes and efficient workflows. My aptitude for planning and problem-solving enables me to navigate complex challenges and find effective solutions. I am dedicated to upholding the highest standards of compliance and ethics in all my work. Through my comprehensive skills and experience, I am committed to contributing to the success of clinical research endeavors.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

Gadolin Research
07.2022 - 05.2023
  • Carried out clinical trials and coordinated multiple study areas including diabetes, psychiatry, women’s health, and pediatrics.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Followed informed consent processes and maintained records.
  • Participated in initiation visits and investigator meetings to implement trials according to study timelines and budgets.
  • Updated case reports and source documents for clinical trials.
  • Worked with principal investigators to facilitate daily trial activities and comply with research protocols.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Handled the maintenance of study regulatory documents, enrollment logs, and drug accountability logs.
  • Screened patient records to identify prospective candidates for research studies.
  • Collaborated with principal investigators and sponsors to facilitate daily trial activities and comply with research protocols.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Maintenance of study regular documents and enrollment logs and drug accountability logs
  • Screened patient records to identify prospective candidates for research studies
  • Collected data and followed research protocols
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

Clinical Research Coordinator

Tekton Research
05.2021 - 05.2022


  • Developed clinical trial protocols.
  • Conducted telephone or in-person screenings.
  • Followed informed consent processes and maintained records.
  • Collected patient vitals and EKGs.
  • Gathered, processed, and shipped lab specimens.
  • Collected, evaluated, and modeled data.
  • Dispensed study-related drugs.
  • Completed case report forms (CRFs).
  • Maintained reports and met with monitors during routine site visits.
  • Ensured regulatory compliance.
  • Coached and mentored CRAs for various aspects of studies.
  • Strengthened communication skills through regular interactions.
  • Successfully worked within tight deadlines and fast-paced environments.
  • Demonstrated a strong commitment to learning and continual improvement.
  • Exhibited excellent verbal and written communication skills.
  • Showed respect, friendliness, and willingness to help wherever needed.
  • Managed time efficiently to meet task deadlines.
  • Worked effectively in fast-paced environments and within a team setting.
  • Demonstrated the ability to learn quickly and adapt to new situations.
  • Self-motivated with a sense of personal responsibility.
  • Skilled at working independently and collaboratively in a team environment.
  • Monitored unit budget to meet financial objectives.
  • Maintained compliance with protocols covering patient care and clinical trial operations.

Clinical Research Associate, Faculty of Medicine

University of Kelaniya
05.2019 - 04.2021
  • Undertook research projects on thalassemia and nephrology, from planning to implementation and writing up.
  • Undertook laboratory procedures and participated in undergraduate teaching.
  • Engaged in subject recruitment for research studies.
  • Conducted informed consent processes.
  • Handled biomedical specimens.
  • Analyzed data gathered from the research projects.
  • Wrote Standard Operating Procedures (SOPs) for various procedures.
  • Delivered undergraduate lectures.
  • Performed laboratory practical sessions.
  • Facilitated small group discussions.
  • Reviewed clinical data, source documentation, case report forms, and investigative site regulatory files to ensure accuracy and completion.
  • Maintained health, safety, and environmental compliance by adhering to procedures, practices, and regulatory requirements.

Scientist

Hemas Hospital Reproductive Health Centre
08.2018 - 03.2019
  • Managed and oversaw the operations of the Andrology Laboratory.
  • Handled patients and performed basic laboratory tests, specifically specimen handling for IUI (Intrauterine Insemination) and IVF (In Vitro Fertilization).
  • Conducted quality control procedures in the Andrology Laboratory.
  • Maintained and handled the system software for medical records of patients.
  • Authorized medical reports.
  • Developed and maintained Standard Operating Procedures (SOPs) specific to Andrology.
  • Organized and conducted research in relevant areas such as Andrology and Subfertility.
  • Provided training to Medical Laboratory Technicians (MLTs) and Nursing staff on IUI procedures.
  • Operated equipment to analyze bodily fluids for anomalies.
  • Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems related to assays or instrumentation.
  • Conducted experiments in a laboratory environment for purposes of product development.

Education

Master of Science -

University of Colombo
Colombo,Sri Lanka
2022

Bachelor of Science -

Northumbria University
Newcastle, United Kingdom
05.2018

Skills

  • Immunology: Understanding of immune system mechanisms, immunological techniques and methods
  • Cell Biology: Knowledge of cell structure and function, cell culture techniques, and microscopy skills
  • Pathology: Familiarity with disease processes, diagnostic techniques, and laboratory procedures
  • Cytology: Understanding of cellular structure and function, cytological staining techniques, and interpretation of cytological samples
  • Statistics: Proficiency in statistical analysis, data interpretation, and experience in using statistical software
  • Histopathology: Competence in tissue sample preparation, staining techniques, and microscope analysis
  • Molecular Biology: Experience in DNA and RNA extraction, PCR techniques, and molecular cloning
  • Laboratory Fundamentals: Proficiency in laboratory safety protocols, sample handling, and equipment operation
  • Communication Skills: Ability to effectively communicate scientific concepts, both orally and in writing
  • Problem Solving: Strong analytical and critical thinking skills to troubleshoot experiments and interpret data

Certification


  • Integrated Approaches to Testing and Assessment (IATA)
  • Good clinical practice(GCP)

Accomplishments

Laboratory Skills:

  • Proficient in DNA Analysis, PCR, Flow cytometer, DNA Extraction, Gel Electrophoresis, and Phlebotomy. I am able to perform these tasks independently.
  • Skilled in Sanger Sequencing, which I can perform under supervision.

Research Skills:

  • In-depth knowledge of clinical drug development, including Clinical Trial Management Systems (CTMS) and GCP (Good Clinical Practice) and IATA (International Air Transport Association) certification.
  • Familiarity with research Standard Operating Procedures (SOPs) and a profound understanding of current drug forms, dosage, strengths, and generics.
  • Experienced in participating in subject recruitment efforts and engaging with subjects to understand their concerns.

Teaching & Mentoring:

  • Selected as a teaching assistant for Principles of Genetics, where I designed and led weekly lecture review and discussion sections for a group of 11 students.
  • Developed course materials, including study problems and exams, and graded problem sets and exams.
  • Coordinated neonatal genetics lectures and conducted weekly genetic questionnaires.

Generic Skills:

  • Proficient in statistical software such as SPSS and MS Office products (Word, Excel, PowerPoint).
  • Familiar with Electronic Medical Records (EMR) systems and experienced in documentation and reporting.
  • Highly adaptable with excellent attention to detail.
  • Possess a strong work ethic and exceptional time management skills.

Scientific communications

  Published as full papers:

  • Yasara, N., Wickramarathne, N., Mettananda, C., Silva, I., Hameed, N., Attanayaka, K., Rodrigo, R., Wickramasinghe, N., Perera, L., Manamperi, A. and Premawardhena, A., 2022. A randomised double-blind placebo-controlled clinical trial of oral hydroxyurea for transfusion-dependent β-thalassaemia. Scientific Reports, 12(1), pp.1-11.
  • Mettananda, S., Pathiraja, H., Peiris, R., Wickramarathne, N., Bandara, D., de Silva, U., Mettananda, C. and Premawardhena, A., 2019. Blood transfusion therapy for βthalassemia major and hemoglobin E Β-Thalassemia: Adequacy, trends, and determinants in Sri Lanka. Pediatric blood & cancer, 66(5), p.e27643.
  • Yasara, N., Wickramarathne, N., et al. (2020) ‘Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: A protocol for randomised double-blind controlled clinical trial’, BMJ Open, 10(10). doi:10.1136/bmjopen-2020-041958.


Published as abstracts :

  • Yasara N, Wickramarathne N, Silva I, Hameed N, Attanayaka A.M.K.R, Jayasinghe V.L, Gunathilaka PACK, Wickramasinghe N, Rodrigo R, Perera L, Perera PS ,Mettanand KCD, Manamperi A, Premawardhena A, Mettananda S (2020). Hydroxyurea for transfusion dependent β-thalassaemia: a randomized double-blind placebo-controlled clinical trial 134th anniversary international medical congress, Sri Lanka Medical Association (SLMA)
  • Yasara N, Wickramarathne N, Silva I, Hameed N, Attanayaka A.M.K.R, Jayasinghe V.L, Gunathilaka PACK, Wickramasinghe N, Rodrigo R, Perera L, Perera PS ,Mettananda KCD, Manamperi A, Premawardhena A, Mettananda S (2020). Hydroxyurea for transfusion dependent β-thalassaemia: a randomized double-blind placebo-controlled clinical trial 133rd anniversary international medical congress, Sri Lanka Medical Association (SLMA)
  • Dharani, K., D. N. U Jayatunge, N. Wickramarathne, S. Thilakarathne, B. A. G. GMahendra. (2021) “Concordance of histological grade between diagnostic core biopsy and corresponding surgical specimen in breast carcinoma; single centre experience.,” Annual Academic Sessions of the College of Pathologist. 121(2021).

Timeline

Clinical Research Coordinator

Gadolin Research
07.2022 - 05.2023

Clinical Research Coordinator

Tekton Research
05.2021 - 05.2022

Clinical Research Associate, Faculty of Medicine

University of Kelaniya
05.2019 - 04.2021

Scientist

Hemas Hospital Reproductive Health Centre
08.2018 - 03.2019

Master of Science -

University of Colombo

Bachelor of Science -

Northumbria University
Nethme Wickramarathne