Leila Sounna
Laurel,MD
Summary
Versatile clinical research professional, knowledgeable about coordinating patient information, data management and regulatory documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in ICH GCP, IATA, and CITI.
Overview
5
5
years of professional experience
Work History
Clinical Research Coordinator II
Medstar Health
12.2021 - Current
- Contributes to the achievement of established department goals and objectives and adheres to department policies, procedures, quality standards and safety standards
- Complies with governmental and accreditation regulations
- Explains the informed consent process and the study to the research participant (e.g., purpose, duration, risks/benefits) and obtains all required signatures: ensures the research participant has sufficient time and opportunity to ask the investigator medical questions; documents the informed consent process in the source document and provides the research participant with a copy of the informed consent
- Recruit research participants and discuss study protocol; educate research participants about protocol expectations and meet with research participants for each visit and maintain accessibility to discuss any questions or concerns regarding the study
- Complete and maintain case report forms (paper and electronic) and review data against the research participant’s medical record for completeness and accuracy
- Address all queries, clarifications and outstanding data queries and appropriately communicate with the sponsor and/or Contract Research Organization (CRO)
- Ensure proper collection, processing and shipment of biospecimens and pharmacokinetics as applicable (e.g., centrifuge, freezing, refrigeration) and maintain current Occupational Safety and Health Administration (OSHA) training regarding Bloodborne Pathogens
- Perform research participant interviews and assessments at study visits as required by protocol
- Document on accountability log and research participant record (e.g., test article received, used, disposed
- Understand and comply with rules for billing Medicare, Medicaid and third-party payors for services, drugs, devices, tests and procedures rendered in the clinical research context
- Responsible for reviewing, understanding, and accepting the billing matrix/billing plan generated by administration for research participants enrolled in clinical studies.
Regulatory Affairs Training
Duke University
07.2023 - 08.2023
- Maintained and archived regulatory paperwork.
- Prepared and submitted regulatory file applications and supporting documentation.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Drug Development and FDA Meetings
- Applicability of FDA Drug Regulations to Clinical Studies.
- IND Content, Format, Review and Maintenance.
- Medical Device Development and FDA Meetings.
- Applicability of FDA Device Regulations to Clinical Studies.
- IDE Preparation, Submission, and Maintenance
Clinical Data Manager
Guidehouse
06.2020 - 12.2022
- In support of the National Institutes of Health National Heart Lung and Blood Institute, oversee the data management of the Genomic Transplant Dynamics Project
- Responsible for performing core data management functions; reviewing process and deliverables, and providing guidance for process modifications to improve downstream efficiencies in data delivery
- Wrote work instruction manuals, data capture guidelines, and standard operating procedures
- Ensure that the data reported for analyses accurately reflect the source data at the clinical trial site
- Completed documentation, recognizing discrepancies, and promptly addressing for resolution
- Conducts Source Document Review of appropriate site source documents and medical records
- Created data management plans and provided input on study designs.
Oncology Clinical Research Coordinator
American Oncology Network
03.2020 - 06.2020
- Facilitate oncology clinical trials by recruiting, screening, enrolling, and providing follow-up care to meet the requirements of protocol
- Maintain all records for drug accountability in coordination with the pharmacist
- Act as a data manager through monitoring and reporting of side effects, disease status, and clinical adherence per guidelines
- Develop enrollment and follow-up guidelines for each protocol and create tools to satisfy all sponsor requirements
- Complete Case Report Forms and provide accurate source documentation in a timely manner
- Coordinate the initiation, maintenance, and closure of protocols in accordance to the guidelines of the Institutional Review Board
- Ensure compliance with Good Clinical Practice Guidelines
- Function as a liaison between the oncologist and subject for all aspects of the oncology clinical trials
- Educate physicians, clinic staff, patients, and families regarding specific protocol requirements, procedures, side effects, risks, and follow-up care
- Serve as a resource for colleagues and an advocate for the patients and families.
Clinical Reseach Coordinator Intern
Accelerated Enrollment Solutions
01.2020 - 02.2020
- Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines
- Schedules subject visits within protocol windows
- Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, etc.)
- Records all patient information and results from tests as per protocol on required forms
- Complete IP accountability logs and associated information
- Reports suspected non-compliance to relevant site staff
- Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study
- Promotes the company and builds a positive relationship with patients to ensure retention
- Contact patients to confirm bookings or provide information or results
- Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
Clinical Research Training
Clinical Research Fastrack
11.2019 - 01.2020
- ICH GCP E6 R (2)
- Informed Consent Process
- FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46
- Clinical Trial Operations from feasibility through close out
- GDP following ALCOA-C principles
- Identification and reporting of AE’s and SAE’s
- Quality Assurance, Monitoring and Query Resolution
- Comprehension and Execution of Clinical Trial Protocols
- Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training logs and other Investigator Site File.
Global Care Consultant
UnitedHealth Group
07.2018 - 07.2019
- Answer a high volume of calls according to client and member specific service requirements
- Manage all aspects of an international and domestics assistance case from opening to close
- Provide superior assistance to customers with travel emergencies, including medical assistance, trip interruption, liability, repatriation, and general customer service
- Review and adhere to client handling instructions for accurate case handling
- First point of contact to coordinate international commercial and non - commercial travel arrangements
- Coordination of care and billing arrangements for travelers experiencing a medical emergency abroad
- Extensive secondary research using a variety of web-based tools
- Maintains timely, accurate documentation for all appropriate transactions
Education
Certificate in Regulatory Affairs - Regulatory Affairs
Duke University
Durham, NC08.2023
Bachelor of Science - Public Health
University of Maryland - College Park
College Park, MD12.2017
Skills
- Oncology Research
- FDA
- Regulatory Guidelines
- Clinical trial Management
- Good Clinical Practice
- Data Management
- Attention to Detail
- Team Collaboration
Timeline
Regulatory Affairs Training
Duke University
07.2023 - 08.2023
Clinical Research Coordinator II
Medstar Health
12.2021 - Current
Clinical Data Manager
Guidehouse
06.2020 - 12.2022
Oncology Clinical Research Coordinator
American Oncology Network
03.2020 - 06.2020
Clinical Reseach Coordinator Intern
Accelerated Enrollment Solutions
01.2020 - 02.2020
Clinical Research Training
Clinical Research Fastrack
11.2019 - 01.2020
Global Care Consultant
UnitedHealth Group
07.2018 - 07.2019
Certificate in Regulatory Affairs - Regulatory Affairs
Duke University
Bachelor of Science - Public Health
University of Maryland - College Park
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