Khyle Sorhaindo
Atlanta,Ga
Summary
Dynamic and detail-oriented Clinical Research Associate (CRA) with 3+ years of on-site monitoring experience across Phases I–III clinical trials. Skilled in oncology, cardiology, women’s health, immunology, neurology, rheumatology, and medical devices. Proficient in Medidata Rave EDC, Veeva Vault, and IQVIA IRT, with expertise in SDV/SDR, GCP/ICH compliance, and investigational product accountability. Experienced in conducting site initiation, monitoring, and close-out visits, supporting sponsor audits with zero major findings, and collaborating with site staff to ensure data accuracy, regulatory compliance, and trial integrity.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II
Icon Plc
08.2023 - Current
- Led and coordinated Phase I-III clinical trials in cardiovascular, neurological, immunological, rheumatological, and oncological therapeutic areas, ensuring adherence to protocols and regulatory requirements.
- Conducted site initiation, monitoring, and close-out visits, maintaining accurate documentation and ensuring compliance with GCP and ICH guidelines.
- Developed and implemented study-specific training materials for site personnel, ensuring protocol adherence and data integrity.
- Collaborated with cross-functional teams to manage study timelines, budgets, and deliverables, contributing to the successful completion of multiple trials.
- Provided support and guidance to investigative sites, resolving queries and issues promptly to ensure study progress and data quality.
- Conducted regular site audits and assessments to identify and mitigate risks, ensuring study conduct in accordance with SOPs and regulatory standards. Contributed to the preparation and review of study documents, including protocols, informed consent forms, and clinical study reports.
- Participated in investigator meetings and study team discussions, providing valuable insights and recommendations for protocol amendments and study improvements.
- Responsibly managed and supervised the implementation of protocol specific duties for 8 different protocols for over 13 sites across the United States.
Clinical Research Associate
Syneos Health
06.2022 - 07.2023
- Championed the adherence to Good Clinical Practice, investigator integrity, and compliance with all study procedures through the vigilant monitoring of all SSV, SIV, IMV, and COV duties.
- Exhibited a sharp eye for detail and an unwavering commitment to quality, ensuring that all site management and performance activities were executed flawlessly, with documentation that was always complete, accurate, and timely.
- Spearheaded all in-house and on-site monitoring for all visit types, leveraging a deep understanding of the specific protocols, trial designs, and scientific objectives to deliver exceptional results.
- Drove improvements in site performance and operational efficiency through proactive identification of potential issues and development of targeted solutions.
- Collaborated closely with cross-functional teams, including study coordinators, investigators, and site staff, to deliver timely and accurate data, driving better decision-making and faster clinical development timelines.
Clinical Trials Equipment Specialist /Project Coordinator
Myonex
10.2021 - 05.2022
- Produced, coordinated, and organized over 156 shipments of medical supplies to designated CROs, hospitals, and universities across 70 different countries and regions, ensuring timely delivery and equipment management.
- Coordinated the shipment and outsourcing of patient solutions to designated clients, ensuring optimal good documenting practice of files and paperwork, resulting in streamlined documentation processes and improved accuracy.
- Cultivated valuable global relationships with clients by providing excellent customer service and punctual email communication, leading to improved client satisfaction and retention.
- Collaborated closely with drug supply services to ensure seamless operation of trials and studies, resulting in timely and accurate supply of medical equipment and materials to clinical trial sites.
- Collaborated with clients in the pre-project planning phase and assisted in the creation of protocol-specific Distribution Instructions, Drug or Equipment, and Ancillary Shipment Request templates and project documentation, leading to improved project planning and execution.
Clinical Trials Research Assistant
Wake Research
05.2021 - 10.2021
- Conducted data entry tasks with precision and accuracy by efficiently logging and organizing over 100 patient data into the database, ensuring all the data were up-to- date and error-free.
- Demonstrated excellent communication skills by updating 15 patients daily via email about clinical trials and appointment information, ensuring they were well- informed and satisfied with the services provided.
- Demonstrated exceptional organizational skills by sorting and filing hundreds of studies into respective binders and folders, resulting in optimal organization and easy accessibility for the entire team.
- Contributed significantly to the weekly staff meetings by analyzing data and presenting insights that facilitated a 50% increase in patient recruitment, ultimately resulting in better outcomes for clinical trials.
- Delivered professional care and compassion to patients, ultimately increasing patient satisfaction and garnering 5-star reviews.
- Successfully executed patient recruitment and boosted participation by 15% by delivering thorough and accurate information regarding the clinical trials, resulting in more informed patients and ultimately better outcomes for the trials.
- Assisted in writing and formulating SOPs for cardiovascular study related protocol devices by detailing step-by-step instructions outfitted with visual aids and troubleshooting.
Education
Bachelor of Science - Healthcare Administration
Purdue University Global
09.2021
Skills
- Clinical trial monitoring (SSV, SIV, IMV, COV)
- Source Data Verification (SDV) & Source Data Review (SDR)
- Good Clinical Practice (GCP) & ICH E6(R2/R3) compliance
- Protocol and Informed Consent Form (ICF) compliance
- Investigational product accountability (storage, reconciliation, supply tracking)
- Risk-Based Monitoring (RBM) & issue escalation
- Regulatory document review (1572, safety reports, IRB/EC submissions)
- Audit readiness (sponsor, CRO, FDA inspections)
- Medidata Rave EDC Veeva Vault eTMF Oracle InForm EDC IQVIA IRT/IXRS
- Clinical Trial Management Systems (CTMS)
- Microsoft Word, Excel, PowerPoint (reporting & site communications)
Certification
- The International Accrediting Organization for Clinical Research F-IAOCR #6567748
- Icon Plc Special CRA Recognition Award
Timeline
Clinical Research Associate II
Icon Plc
08.2023 - Current
Clinical Research Associate
Syneos Health
06.2022 - 07.2023
Clinical Trials Equipment Specialist /Project Coordinator
Myonex
10.2021 - 05.2022
Clinical Trials Research Assistant
Wake Research
05.2021 - 10.2021
Bachelor of Science - Healthcare Administration
Purdue University Global