Clinical Trial Associate

Job Description:

• Provides administrative support to clinical trial team
• Triages incoming emails, as needed, for task or project team.
• Assists in the tracking, distribution, filing and organizing of clinical trial or project records, e.g., protocol deviations, site monitoring visit reports, essential regulatory documents (ERDs), non-disclosure agreements, travel arrangements, progress reports, project plans etc.
• Assists in generating project status or progress reports, presentations, and study documents and distributing to internal and/or external stakeholders.
• Reviews information in centralized databases, e.g., patient recruitment/accrual, clinical data entered as EDC. Resolve queries, provide analysis assessments, and create/distribute periodic reports to internal and external stakeholders. May participate in centralized monitoring visits (CMVs), or assist In-House CRAs or field CRAs with preparation for visits and review of documents.
• Provide in-person or virtual/hybrid meeting Support, i.e., coordinate and schedule study-related activities such as Investigator Meetings and other trainings.
• Distribute meeting invites, track attendance, and document key decisions, discussion and action items in meeting minutes.
• Adherence to strict project timelines and expectations.
• Troubleshoot and problem solve issues by applying existing knowledge.
• Assist with other clinical operational activities when required, including tracking of project tasks, study progress and CRA visit schedules.
• Assist CRAs, CSMs, and/or In-House CRAs as needed.

Requirements:

• Knowledge of applicable ICH/GCP/FDA guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-house CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
• Must have excellent time management skills.
• Able to identify activities along critical paths toward a specified deliverable.
• Demonstrated understanding of medical and clinical trials terminology, including general understanding of Clinical Site Monitoring, Essential Regulatory Documents, and Trial Master Files.
• Able to work independently or with minimal supervision and handle multiple tasks effectively while keeping up with rapid changes of priorities without loss of efficiency.
• Demonstrated understanding of sponsor-specific requirements, and Standard Operating Procedures/Project Work Instructions.
• Excellent professional writing and verbal communication skills.
• Must be self-motivated and have a positive attitude.
• Proficient with Microsoft Office (Outlook, Word, PowerPoint, Excel) and ability to learn other systems as needed.
• Excellent organizational and coordination skills with strong attention to detail.

Education:

• B.A/B.S. in health-related field preferred, or understanding of data and/or documentation handling

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals.To learn more, please visit https://dexian.com/.

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.