Sarah Mounib
Raleigh,NC
Summary
Clinical Research professional skilled in supporting Phase II-IV clinical trials across diverse therapeutic areas such as CNS, Vaccines, Oncology, Radiopharmaceuticals, and Gastroenterology. Currently serving as a Site Management Associate I, executing CRA functions with a focus on remote document review verification, regulatory compliance, IP accountability, and collaboration with CRAs and investigator sites to ensure adherence to Good Clinical Practice.
Overview
9
9
years of professional experience
2
2
Certifications
Work History
Site Management Associate I
PSI CRO AG
01.2025 - Current
- Executed in-house CRA functions to enhance support for investigator sites in sponsor-led clinical trials.
- Tracked site deliverables and coordinated with CRAs to ensure readiness of sites for monitoring visits.
- Conducted remote reviews and verifications of ISF/EISF documents to ensure regulatory compliance.
- Analyzed data from clinical trials to support decision-making processes.
- Leveraged communication and problem-solving abilities to alleviate ongoing issues and promote conflict resolution.
- Prepared comprehensive reports and presentations to effectively communicate findings in internal and external meetings.
Acting Clinical Research Coordinator - CNS
Velocity Clinical Research
10.2023 - 01.2025
- Coordinated clinical trials, overseeing startup, recruitment, scheduling, protocol training, regulatory document collection, study visits, and adverse event reporting to ensure compliance and data integrity.
- Conducted patient prescreening, managed EDC data entry and query resolution, supported investigational product administration, phlebotomy, ECG collection, and lab processing.
- Therapeutic experience includes Alzheimer's disease, Parkinson's disease, multiple sclerosis, migraine, dementia, sleep apnea, and epilepsy.
- Trained new staff on clinical trial protocols and procedures, enhancing team knowledge and operational efficiency.
Clinical Start Up Regulatory Affairs Specialist
Labcorp Drug Development
10.2022 - 05.2023
- Coordinated regulatory submissions and reviewed documentation, ensuring compliance with FDA and ICH guidelines to support timely project advancement.
- Utilized Veeva Vault, CIRBI, SAMS, Advarra, Rave CTMS, and eTMF systems to streamline regulatory processes and enhance submission efficiency.
- Developed regulatory documentation, maintaining readiness for audits and inspections.
- Managed regulatory changes due to new laws, communicating requirements and assessing operational impacts to minimize disruption in operations.
Medical Assistant
Cary Neurology and Sleep Disorders
11.2019 - 12.2021
- Executed clinical and administrative tasks, facilitating patient intake and accurate vital signs assessment.
- Assisted physicians during examinations and maintained comprehensive patient medical records.
- Ensured HIPAA compliance throughout all patient interactions and documentation processes.
- Managed insurance verification processes, improving patient access to care services.
- Coordinated office operations, focusing on effective filing systems and document management.
- Oversaw budgeting and inventory management to maximize operational efficiency.
- Streamlined procedures, optimizing workflow and enhancing patient experience.
Clinical Research Assistant (Intern)
Boice Willis Clinic
06.2020 - 07.2021
- Streamlined clinical trial operations through regulatory documentation management and study preparation.
- Coordinated participant recruitment and scheduling for multiple clinical trials, enhancing study enrollment and timeline adherence.
- Collected and organized data for regulatory submissions, ensuring compliance with standards and facilitating timely approvals.
- Managed inventory of research supplies and equipment, supporting studies effectively.
- Educated clinical study participants while proactively addressing concerns.
- Developed tracking systems for regulatory submissions, streamlining processes for IRB applications and safety reports.
Inside Sales Representative
Hewlett-Packard Company
Raleigh, North Carolina
02.2018 - 08.2019
- Managed customer accounts and sales processes, consistently exceeding performance metrics.
- Generated sales through outbound calling and effective lead follow-up techniques.
- Conducted product demonstrations that effectively highlighted key features and benefits, leading to increased customer interest.
- Utilized CRM software to track sales activities and customer interactions, enhancing follow-up efficiency.
- Cultivated customer relationships, driving revenue growth through engagement.
- Analyzed market trends to identify new sales opportunities within accounts.
- Collaborated with marketing teams to develop promotional strategies and campaigns.
- Provided training and support for new sales representatives at HP.
Customer Service Representative
Conn's HomePlus
07.2017 - 12.2017
- Delivered exceptional customer support while managing product sales and client accounts, resulting in increased customer loyalty.
- Promoted high customer satisfaction by resolving issues effectively and providing friendly service, contributing to positive customer feedback.
- Assisted customers with product selection, ordering, billing, returns, exchanges, and technical support.
- Processed transactions accurately using point-of-sale systems and software.
- Developed strong customer relationships that encouraged repeat business and enhanced customer retention.
- Provided thorough product knowledge training to new team members and peers.
- Facilitated inventory management by tracking stock levels and replenishing items.
Education
High School Diploma -
Rocky Mount Senior High School
Rocky Mount, NC01-2017
Human Biology - Sciences
North Carolina State University
Raleigh, North CarolinaSkills
- Core clinical research skills
- Clinical trial management systems
- GCP and ICH compliance
- Protocol compliance
- Regulatory submissions
- Investigator site file review
- EDC data entry and query resolution
- CRIO and Veeva Vault
- RAVE and Clinical Conductor
- Investigational product accountability
- Patient coordination
- Sponsor and site communication
- Phlebotomy and ECG skills
- Lab processing techniques
Certification
• Good Clinical Practice (GCP)
• IATA Dangerous Goods Certification
• C-SSRS Suicide Severity Rating Scale
• BLS / AED Certification
• IATA Dangerous Goods Certification
• C-SSRS Suicide Severity Rating Scale
• BLS / AED Certification
Timeline
Site Management Associate I
PSI CRO AG
01.2025 - Current
Acting Clinical Research Coordinator - CNS
Velocity Clinical Research
10.2023 - 01.2025
Clinical Start Up Regulatory Affairs Specialist
Labcorp Drug Development
10.2022 - 05.2023
Clinical Research Assistant (Intern)
Boice Willis Clinic
06.2020 - 07.2021
Medical Assistant
Cary Neurology and Sleep Disorders
11.2019 - 12.2021
Inside Sales Representative
Hewlett-Packard Company
02.2018 - 08.2019
Customer Service Representative
Conn's HomePlus
07.2017 - 12.2017
High School Diploma -
Rocky Mount Senior High School
Human Biology - Sciences
North Carolina State University