Sasha Saint-Lot
Leland,NC
Summary
Results-driven clinical research professional with expertise in GCP compliance, IRT systems, and site start-up management. Proven ability to enhance patient enrollment strategies and mentor cross-functional teams.
Overview
7
7
years of professional experience
Work History
Team Lead
Accellacare
Wilmington, NC
04.2022 - Current
- Direct cross-functional clinical research teams, ensuring protocol adherence, and regulatory compliance.
- Mentor and supervise clinical staff, fostering performance excellence, and maintaining a high standard of GCP-aligned operations.
- Oversee all phases of trial conduct, including participant enrollment, informed consent, data entry, and adverse event documentation.
- Collaborate with sponsors, CROs, and monitors to ensure timely and accurate reporting through systems such as Veeva Vault, IRT, and EDC.
- Spearhead workflow optimizations that improved study start-up timelines, and enhanced patient retention rates.
- Conduct internal audits and readiness assessments, ensuring inspection preparedness for the FDA, IRB, and sponsor visits.
Certified Clinical Research Coordinator Level III
Accellacare
Wilmington, NC
04.2021 - 04.2022
- Led complex clinical trials from initiation to close-out, ensuring strict adherence to GCP, IRB, and protocol standards.
- Acted as primary liaison between site, sponsors, and CROs for study updates, monitoring visits, and issue resolution.
- Managed informed consent processes and ensured accurate documentation for high-risk patient populations.
- Recorded, tracked, and reported adverse events and deviations promptly, supporting regulatory transparency.
- Trained junior coordinators and support staff, contributing to improved study accuracy and team competency.
- Utilized EDC platforms and IRT systems to ensure timely and high-quality data submission.
Certified Clinical Research Coordinator Level II
Accellacare
Wilmington, NC
06.2020 - 04.2021
- Coordinated day-to-day clinical trial operations including patient recruitment, consent, visit scheduling, and data collection.
- Maintained accurate and timely documentation in CTMS, EDC, and IRT systems to ensure regulatory compliance.
- Collaborated with investigators and sponsors to track protocol adherence, manage study timelines, and resolve discrepancies.
- Recorded adverse events and supported follow-up procedures to maintain subject safety and data integrity.
- Ensured audit-readiness by preparing regulatory documents, source data, and site files in alignment with SOPs.
- Supported protocol amendments, informed consent revisions, and IRB submissions as studies evolved.
Certified Clinical Research Coordinator Level I
Accellacare
Wilmington, NC
03.2019 - 06.2020
- Executed clinical trial procedures including subject screening, enrollment, and follow-up under PI supervision.
- Collected and entered source data into EDC systems, maintaining data accuracy and consistency across all visits.
- Conducted protocol-specific assessments and documented findings in accordance with GCP guidelines.
- Managed study drug accountability, including receipt, storage, dispensation, and return documentation.
- Assisted with regulatory binders, IRB correspondence, and study file organization for ongoing trials.
- Participated in sponsor and monitor visits to ensure protocol compliance and audit readiness.
Clinical Research Coordinator Assistant
Accellacare
Wilmington, NC
02.2018 - 03.2019
- Supported lead coordinators in executing study visits, maintaining patient schedules, and preparing visit documentation.
- Assisted in the collection of vital signs, lab samples, and ECGs, ensuring protocol compliance and patient safety.
- Helped manage subject charts, case report forms, and source documents to support data accuracy and completeness.
- Coordinated with labs and couriers for timely specimen processing and shipment per study protocols.
- Prepared exam rooms and study materials to streamline visit flow and improve patient experience.
- Shadowed PI and CRCs during assessments to deepen protocol understanding and clinical research knowledge.
Clinical Research Intern
Accellacare
Wilmington, NC
09.2017 - 02.2018
- Observed and assisted in the conduct of clinical trials, gaining hands-on exposure to regulatory documentation and study coordination.
- Helped prepare regulatory binders, consent forms, and data entry logs under CRC supervision.
- Participated in patient check-ins and supported scheduling, chart reviews, and visit preparation.
- Conducted literature reviews and protocol overviews to support trial feasibility assessments.
- Learned fundamentals of GCP, IRB submission processes, and clinical trial site operations through shadowing and guided tasks.
Histotechnician
Bluewater Dermatology
Whiteville, NC
09.2017 - 02.2018
- Processed and prepared tissue samples using microtomes and staining techniques to support dermatopathology diagnosis.
- Maintained and calibrated laboratory equipment including cryostats, embedding centers, and microscopes.
- Applied histochemical stains to enhance cellular detail and assist in accurate tissue interpretation.
- Ensured timely delivery of prepared slides to pathologists, supporting efficient diagnostic turnaround.
- Adhered to lab safety standards and documentation protocols for specimen tracking and quality assurance.
Histotechnician
Summit Plastic Surgery and Dermatology
Wilmington, NC
05.2014 - 09.2017
- Prepared tissue specimens for microscopic examination to aid in the diagnosis and treatment of dermatologic conditions.
- Identified key histological structures and ensured proper sectioning, embedding, and staining procedures.
- Collaborated with surgeons and lab staff to process surgical specimens and support real-time pathology reviews.
- Maintained detailed logs and specimen records in compliance with CLIA and laboratory quality standards.
- Operated and maintained lab instruments to ensure consistent performance.
Education
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Wilmington, NC05.2018
Associate of Science - Pre-Nursing
Cape Fear Community College
Wilmington, NC05.2017
Associate of Science - Medical Assisting
Florida Metropolitan University
Melbourne, FL05.2003
Skills
- Clinical systems and technology
- Study start-up and feasibility
- FDA regulatory compliance
- Clinical operations and monitoring
- Cross-functional management
- Project coordination
- Team leadership
- Clinical trial management
- GCP and ICH compliance
Complementary Experience And Qualifications - Certifications
- Certified Clinical Research Coordinator (CCRC), Current
- OSHA Safety Certification, Up to Date
- CPR (Cardiopulmonary Resuscitation), Active
Technical Skills
Veeva Vault, IRT Systems, EDC Platforms, CTMS, EMR, Histology Techniques, Microtomy, Specimen Processing, Lab Equipment Maintenance, GCP Guidelines, FDA & IRB Standards, Audit Readiness, Documentation & Reporting, Microsoft Office Suite, Data Entry & Management, Scheduling Systems, Patient Communication, Team Leadership, Cross-functional Collaboration, Staff Training
Timeline
Team Lead
Accellacare
04.2022 - Current
Certified Clinical Research Coordinator Level III
Accellacare
04.2021 - 04.2022
Certified Clinical Research Coordinator Level II
Accellacare
06.2020 - 04.2021
Certified Clinical Research Coordinator Level I
Accellacare
03.2019 - 06.2020
Clinical Research Coordinator Assistant
Accellacare
02.2018 - 03.2019
Clinical Research Intern
Accellacare
09.2017 - 02.2018
Histotechnician
Bluewater Dermatology
09.2017 - 02.2018
Histotechnician
Summit Plastic Surgery and Dermatology
05.2014 - 09.2017
Bachelor of Science - Clinical Research
University of North Carolina Wilmington
Associate of Science - Pre-Nursing
Cape Fear Community College
Associate of Science - Medical Assisting
Florida Metropolitan University
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