Malik Glast
Raleigh,North Carolina
Summary
Detail-oriented and proactive Clinical Research Associate with 2.5+ years of experience in study start-up, site communication, and clinical trial coordination. Skilled in regulatory documentation, protocol adherence, and maintaining compliance for global clinical trials. Proven ability to manage multiple priorities while ensuring the accuracy and quality of trial documentation. Adept at fostering productive relationships with investigators, site staff, and cross-functional teams to drive successful trial execution. Recognized for excellence in clinical operations, with a strong foundation in data management, study monitoring, and FDA compliance.
Overview
7
7
years of professional experience
Work History
Clinical Trial Assistant
ICON PLC
Raleigh, NC
02.2022 - 05.2024
- Led study start-up activities, including regulatory document review, site activation tasks, and ensuring IRB submissions met compliance standards
- Served as a key contact for site communication, coordinating with investigators and site staff to ensure timely completion of site-specific regulatory requirements
- Monitored Trial Master File (TMF) progress and worked closely with Clinical Project Managers (CPMs) to reconcile discrepancies and obtain IRB IIP approvals
- Ensured FDA 1572 documentation compliance, reviewing investigator disclosures for accuracy and addressing potential conflicts of interest
- Supported CRAs by assisting with clinical monitoring, site data reviews, and adverse event reporting to safeguard patient safety
- Conducted training for six incoming CTAs on study-specific guidelines, improving onboarding efficiency and ensuring compliance with SOPs
- Recognized with two company-sponsored awards for professionalism and adherence to project compliance, as well as media acknowledgment for vaccine study efforts (Adult RSV)
Deputy Clerk
Wake County Justice Center
Raleigh, NC
05.2020 - 02.2022
- Managed, processed, and maintained court documents and legal trial records, ensuring accuracy and compliance with judicial regulations
- Provided administrative support for court proceedings, including scheduling, meeting preparation, and compliance monitoring
- Promoted to Deputy Clerk for DWI and Domestic Violence court proceedings, demonstrating strong organizational and operational management skills
Technician
Trident Technology Solutions
Raleigh, NC
06.2017 - 12.2019
- Installed, managed, and troubleshot structured cabling and networking solutions, ensuring reliability and high performance for business communication systems
- Conducted routine inspections and maintenance of fiber optic and wired networks to improve efficiency and capacity
Education
Bachelor of Applied Arts & Sciences - Sociology
University of North Carolina at Greensboro
Greensboro, NCBachelor of Arts - Media Studies
University of North Carolina at Greensboro
Greensboro, NCSkills
- Study start-up and site activation
- Site communication and relationship management
- FDA 1572 documentation and conflict-of-interest compliance
- Protocol development and regulatory submissions
- Informed Consent Form (ICF) reconciliation
- Adverse Event (AE) reporting and patient safety monitoring
- Clinical Trial Management Systems (CTMS)
- Oracle
- Siebel
- PTMF
- ETMF
- Medidata
- Veeva Vault
- Secure Consent
- Firecrest
- Microsoft Office Suite
- Box
- Zoom
- WebEx
- Adult RSV
- Ulcerative Colitis
- Pediatric/adult vaccine studies
- Training and mentoring
- Regulatory submissions
- Standard operating procedures
- Study coordination
- IRB and IEC submissions
References
- Lillie Jackson, Lillie.jackson@iconplc.com, (267) 250-5435
- Jimmin Dong, Jimmin.Dong@iconplc.com, (919) 909-1342
Languages
- English, Professional
- Spanish, Conversational
Skills
Study start-up and site activation, Site communication and relationship management, FDA 1572 documentation and conflict-of-interest compliance, Protocol development and regulatory submissions, Informed Consent Form (ICF) reconciliation, Adverse Event (AE) reporting and patient safety monitoring, Clinical Trial Management Systems (CTMS): Oracle, Siebel, PTMF, eTMF, Medidata, Tools: Veeva Vault, Secure Consent, Firecrest, Microsoft Office Suite, Box, Zoom, WebEx, Adult RSV, Ulcerative Colitis, pediatric/adult vaccine studies
Timeline
Clinical Trial Assistant
ICON PLC
02.2022 - 05.2024
Deputy Clerk
Wake County Justice Center
05.2020 - 02.2022
Technician
Trident Technology Solutions
06.2017 - 12.2019
Bachelor of Applied Arts & Sciences - Sociology
University of North Carolina at Greensboro
Bachelor of Arts - Media Studies
University of North Carolina at Greensboro