Job Title: Clinical Trial Associate (CTA)
Location: Bethesda, MD (Hybrid)
Duration: Contract to Hire
Salary Range: $25 to $40/hr (After conversion to FTE $60K to $80k/annum)
Job Description:
The Clinical Trial Associate (CTA) provides critical operational and administrative support to Clinical Operations teams to ensure the successful execution of clinical trials. This role supports study teams across multiple phases by managing trial documentation, tracking study activities, coordinating meetings, and supporting monitoring activities in compliance with ICH/GCP and regulatory requirements. The CTA plays a key role in maintaining study organization, timelines, and audit readiness.
Key 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.
Qualifications:
- 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.
- Bachelor’s degree in a health-related field preferred, or equivalent experience in data and documentation handling.
Ideal Candidate Profile:
- 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.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
