Dexian · 8 hours ago
Clinical Trial Associate
Dexian is a leading provider of staffing, IT, and workforce solutions. The Clinical Trial Associate (CTA) provides critical operational and administrative support to Clinical Operations teams to ensure the successful execution of clinical trials, managing trial documentation, coordinating meetings, and supporting monitoring activities in compliance with regulatory requirements.
Responsibilities
Provide administrative and operational support to clinical trial teams across ongoing studies
Triage and manage incoming study-related communications, escalating items as appropriate
Track, organize, file, and distribute clinical trial documentation, including Essential Regulatory Documents (ERDs), protocol deviations, monitoring visit reports, NDAs, and project records
Support Trial Master File (TMF) maintenance to ensure accuracy, completeness, and inspection readiness
Assist in generating and distributing project status reports, presentations, and study documentation to internal and external stakeholders
Review and analyze data from centralized systems (e.g., EDC, recruitment/accrual tools), resolve queries, and prepare periodic reports
Support centralized monitoring activities and assist In-House CRAs or Field CRAs with visit preparation and document review
Coordinate and support investigator meetings, trainings, and study-related meetings (virtual, hybrid, or in-person)
Schedule meetings, distribute invites, track attendance, and document meeting minutes, decisions, and action items
Track study tasks, milestones, and CRA visit schedules to ensure adherence to project timelines
Troubleshoot operational issues using established procedures and escalating as needed
Support additional clinical operations activities as required
Qualification
Required
Working knowledge of ICH/GCP and FDA regulations within a clinical research, pharmaceutical, CRO, sponsor, or clinical site environment
Understanding of clinical trial processes, medical terminology, site monitoring activities, and regulatory documentation
Strong organizational, coordination, and time management skills with high attention to detail
Ability to manage multiple priorities independently in a fast-paced environment
Demonstrated ability to identify critical path activities and meet project deliverables
Excellent written and verbal communication skills
Proficiency in MS Office (Outlook, Word, Excel, PowerPoint); ability to learn new systems quickly
Preferred
Bachelor's degree in a health-related field preferred, or equivalent experience in data and documentation handling
0–2 years of clinical research experience for CTA I; 2–4 years for CTA II; 5+ years for CTA III
Background as a Research Assistant, Study Coordinator, Regulatory or IRB Coordinator, or In-House CRA is highly preferred
Detail-oriented professional who thrives in structured, compliance-driven environments
Proactive, self-motivated, and comfortable working with minimal supervision
Strong collaborator who communicates effectively with CRAs, Clinical Study Managers, and cross-functional teams
Career-driven individual looking to grow within Clinical Operations or advance toward CRA or Study Management roles
Company
Dexian
Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.
H1B Sponsorship
Dexian has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (65)
Funding
Current Stage
Late StageRecent News
2025-11-19
Company data provided by crunchbase