Accomplished Clinical Research Associate with 2 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
3
3
years of professional experience
Work History
Clinical Research Associate 1
Techtrials - Healthcare Data Science
2022.05 - 2023.08
Prepared high-quality final reports upon completion of clinical trials documenting results achieved through careful monitoring of data trends.
Improved data quality by conducting thorough source document verification and resolving discrepancies in timely manner.
Collected and documented patient medical information such as blood pressure and weight.
Participated in selection of appropriate clinical sites by evaluating potential locations and assessing capacity for successful trial outcomes.
Contributed to successful trial completion by tracking patient progress and maintaining regular communication with study participants.
Assisted in development of study-specific materials, including informed consent forms and case report forms, to ensure proper documentation and adherence to guidelines.
Maintained up-to-date knowledge of industry best practices by attending relevant conferences, workshops, and webinars.
Adaptable and proficient in learning new concepts quickly and efficiently.
Set up and disbanded trial study centers to manage clinical study activities for 150 sites.
Clinical Research Intern
Roche Pharmaceuticals
2021.01 - 2021.07
Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Prepared and maintained regulatory documents for clinical trial submissions.
Supported site monitoring activities including reviewing informed consent documentation, verifying eligibility criteria, and assessing protocol deviations.
Assisted in evaluation of investigational products safety and efficacy, contributing to successful clinical trials.
Managed patient recruitment, informed consent process and data entry to support trial objectives.
Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
Utilized molecular and genetic techniques to detect and diagnose diseases.
Education
Bachelor of Science - Industrial Maintenance Technology
University Presbiterian Mackenzie
Brazil
08.2022
Skills
Data collection techniques
Protocol adherence
Participant screening
Site Management
Protocol Review
Good Clinical Practices
Languages
English
Full Professional
Spanish
Professional Working
Portuguese
Native or Bilingual
Timeline
Clinical Research Associate 1
Techtrials - Healthcare Data Science
2022.05 - 2023.08
Clinical Research Intern
Roche Pharmaceuticals
2021.01 - 2021.07
Bachelor of Science - Industrial Maintenance Technology
University Presbiterian Mackenzie
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