Tech Observer · 2 days ago
Clinical Trial Associate
Tech Observer is seeking a Clinical Trial Associate (CTA) to provide operational and administrative support to clinical trial teams. The CTA will assist with trial documentation, track study progress, and ensure compliance with regulatory requirements throughout the clinical study lifecycle.
Responsibilities
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
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
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
Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.)
Support data entry and reconciliation across clinical systems
Qualification
Required
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
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
Company
Tech Observer
Tech Observer is a pharmaceuticals company that offers clinical research and analytical support services.
H1B Sponsorship
Tech Observer 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 (16)
2024 (12)
2023 (7)
2022 (25)
2021 (12)
2020 (29)
Funding
Current Stage
Growth StageCompany data provided by crunchbase