Nesrine Charara
Plymouth
Summary
Results-driven Clinical Research Coordinator with extensive experience managing interventional and observational trials. Focused on improving clinical research quality through strategic oversight of eSource systems and rigorous data management. Committed to fostering collaboration among cross-functional teams to ensure timely project milestones and compliance with regulatory standards.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Coordinator, Site Lead
Emvenio Research
Detroit
03.2025 - Current
- Led the site's clinical research coordination across multiple interventional and observational trials, overseeing day-to-day execution, timelines, and cross-functional coordination consistent with primary CRC responsibilities.
- Actively supported clinical project management teams by tracking study milestones, escalating risks, and assisting with operational execution across study start-up, maintenance, and close-out phases.
- Collaborated directly with eSource build teams during study start-up, contributing to workflow design, form validation, user acceptance testing (UAT), and issue resolution to ensure protocol-aligned data capture.
- Supported the management of eSource and EDC systems, including real-time data entry, query resolution, quality checks, and reconciliation to support accurate and inspection-ready clinical databases.
- Coordinated CRA interactions, scheduling monitoring visits, leading site-level calls, addressing action items, and resolving data and regulatory queries within defined timelines to ensure compliance and study progress.
- Conducted quality control reviews of source documentation, ensuring consistency between eSource, EHR, and regulatory records in accordance with ICH-GCP and sponsor requirements.
- Coordinated and tracked investigational product logistics, including receipt, storage oversight, temperature documentation, accountability, and reconciliation.
- Oversaw biological specimen collection and processing, managing IATA-compliant shipping and coordinating with laboratories and vendors to maintain protocol compliance and chain-of-custody integrity.
- Maintained regulatory documentation, including study amendments, continuing reviews, eISF, delegation logs, and training records, to ensure continuous audit and inspection readiness.
- Supported study start-up activities, including equipment coordination, vendor communication, document collection, and readiness assessments.
- Acted as primary communication liaison between investigators, sponsors, CROs, CRAs, nurses, vendors, pharmacies, and laboratories to support seamless study execution.
- Processed and tracked site related expenses, reimbursements, and site-level documentation to support financial and operational oversight.
- Participated in decentralized and community-based trial models, supporting recruitment, retention, and execution in diverse and hard-to-reach populations.
- Maintained strict compliance with FDA regulations, HIPAA, ICH-GCP, SOPs, and sponsor-specific requirements across all clinical trial activities.
- Completed training in GCP, HIPAA, and IATA protocols.
Medical Assistant
Henry Ford Health System
MI
06.2024 - 03.2025
- Assisted physicians with procedures including RFA, biopsies, laryngeal botox, excisions, and nasal fracture treatments.
- Supported minor surgical procedures and collaborated with physicians on diagnostic testing and patient care.
- Monitored vital signs and documented patient data, ensuring adherence to medical standards for accurate patient assessments.
- Collected and processed laboratory specimens while upholding PPE and safety protocols to ensure a safe environment for patients and staff.
- Coordinated patient care by scheduling appointments and maintaining precise medical records to enhance continuity of care.
- Prepared examination rooms and ensured all necessary supplies and equipment were available and sterile.
- Conducted data entry of patient information into EHR systems and ensured accuracy in chart documentation.
Medical Assistant
Michigan Medicine
Northville
10.2022 - 06.2024
- Assisted physicians with patient examinations and procedures.
- Managed patient records in electronic health record systems to ensure accurate and timely access to patient information.
- Coordinated patient appointments and follow-up visits effectively.
- Administered medications and vaccinations under supervision.
- Educated patients on treatment plans and health maintenance strategies to promote better health outcomes.
- Supported medical staff by preparing examination rooms promptly.
- Conducted basic laboratory tests and prepared specimens for analysis.
- Maintained inventory of medical supplies and equipment efficiently.
- Kept examination rooms clean, stocked with necessary supplies and prepared for incoming patients.
- Adhered to HIPAA regulations regarding safeguarding confidential patient information at all times.
- Documented notes during patient visits.
- Maintained accurate medical records through efficient filing, charting, transcription, and data entry in electronic health record system.
- Conducted EKGs, spirometry testing, audiograms, and other diagnostic tests.
- Ordered medical supplies, maintained inventory logs, and restocked exam rooms.
- Contacted pharmacies to submit and refill patients' prescriptions.
- Assisted with pre-operative preparation of patients including providing instruction about post-operative care plans.
- Changed dressings on wounds to prevent infection and check for healing.
Medical Assistant
11.2018 - 02.2020
- Utilized hospital systems to monitor and report on individual patient care, including lab results, allergies, and vital signs.
- Provided direct patient care, including medication administration and monitoring.
- Supported residents with daily activities and coordinated with healthcare teams to ensure high-quality care.
- Performed data entry for patient care records and maintained accurate documentation.
Education
Master's - Business Administration, Healthcare Management
Baker College
Bachelor of Science - Health and Human Services
University of Michigan
Ann ArborSkills
- Trial coordination
- Clinical data management
- Study start-up execution
- Informed consent process
- IRB submissions
- Regulatory compliance
- Good clinical practice
- Data quality assurance
- Investigational product management
- Site management
- Recruitment strategies
- EDC systems management
- Medical documentation management
- Cross-functional teamwork
- Team leadership
- HIPAA regulations adherence
- Trial management
- Investigator coordination
Certification
- BLS Provider, AHA
- HIPAA for Education and Research, CITI
- OSHA Bloodborne Pathogens, CITI
- Transport of Regulated Biological Materials, CITI
- GCP for Clinical Trials, CITI
- Certified Medical Assistant, American Allied Health
- C-SSRS, CITI
- ICH-R6 E3, CITI
References
Renee Dwaihy, Principal Investigator, EmVenio Research (313-850-6475)
Stephanie Senvisky, Director of Regulatory Affairs, Civia Health (330-402-2662)
Samaa Rizk, Senior Project Manager, PCM Trials (313-712-0029)
Timeline
Lead Clinical Research Coordinator, Site Lead
Emvenio Research
03.2025 - Current
Medical Assistant
Henry Ford Health System
06.2024 - 03.2025
Medical Assistant
Michigan Medicine
10.2022 - 06.2024
Medical Assistant
11.2018 - 02.2020
Master's - Business Administration, Healthcare Management
Baker College
Bachelor of Science - Health and Human Services
University of Michigan