Clinical Trial Associate

Tech Observer; Paramus (NJ); Hybrid; USD 60,000 - 80,000; Full time

Job summary

A clinical research organization is looking for a dependable Clinical Trial Associate to provide crucial operational and administrative support to clinical trial teams. The ideal candidate will assist with trial management, documentation, and regulatory compliance. Responsibilities include maintaining trial documentation, tracking study progress, and ensuring adherence to guidelines. A Bachelor's degree in a relevant field and 1–3 years of experience in clinical research are required. The position may be office-based, hybrid, or remote and could require occasional travel for meetings.

Qualifications

• 1–3 years of experience in clinical research or clinical trial operations.
• Basic understanding of clinical trial processes and ICH-GCP guidelines.
• Experience working with eTMF and CTMS systems.

Responsibilities

• Support study start-up, conduct, and close-out activities across assigned clinical trials.
• Maintain the Trial Master File (TMF) ensuring completeness and accuracy.
• Assist with regulatory submissions and compliance documentation.

Skills

Organizational skills

Written communication

Verbal communication

Attention to detail

Coordination

Education

Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field

Tools

eTMF

CTMS

MS Office (Excel, Word, PowerPoint)

Job description

The Clinical Trial Associate (CTA) provides essential operational and administrative support to clinical trial teams to ensure the effective planning, execution, and close-out of clinical studies. The role supports Clinical Research Associates (CRAs), Clinical Trial Managers (CTMs), and project teams in maintaining trial documentation, tracking study progress, and ensuring compliance with ICH-GCP, SOPs, and regulatory requirements.

Key Responsibilities

Trial Management Support

• Support study start-up, conduct, and close-out activities across assigned clinical trials
• Assist CRAs and CTMs with day-to-day trial operations and coordination
• Track study milestones, deliverables, and timelines

Documentation & TMF Management

• Maintain the Trial Master File (TMF) ensuring completeness, accuracy, and inspection readiness
• Collect, review, file, and archive essential study documents
• Support TMF quality checks and reconciliation activities
• Support site initiation, monitoring, and close-out activities
• Track site documents including CVs, training records, regulatory approvals, and essential correspondence
• Coordinate logistics for investigator meetings, monitoring visits, and study materials

Regulatory & Compliance Support

• Assist with regulatory submissions and maintenance of regulatory files
• Ensure documentation complies with ICH-GCP, SOPs, and applicable regulations
• Support audit and inspection readiness activities

Data & System Management

• Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.)
• Support data entry and reconciliation across clinical systems

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field
• 1–3 years of experience in clinical research or clinical trial operations
• Basic understanding of clinical trial processes and ICH-GCP guidelines
• Experience working with eTMF and CTMS systems
• Strong organizational and documentation skills
• Excellent written and verbal communication abilities

Preferred Qualifications

• Experience in CRO or FSP environment
• Exposure to global clinical trials
• Experience supporting Phase I–IV clinical studies
• Familiarity with sponsor-specific SOPs and processes
• Attention to detail and quality focus
• Strong coordination and follow-up skills
• Ability to manage multiple tasks and timelines
• Collaborative team player
• Proficiency in MS Office (Excel, Word, PowerPoint)
• Office-based / hybrid / remote (as applicable)
• May require occasional travel for investigator meetings or training