Clinical Trial Associate

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 trialsAssist CRAs and CTMs with day-to-day trial operations and coordinationTrack study milestones, deliverables, and timelinesDocumentation & TMF Management Maintain the Trial Master File (TMF) ensuring completeness, accuracy, and inspection readinessCollect, review, file, and archive essential study documentsSupport TMF quality checks and reconciliation activitiesSupport site initiation, monitoring, and close-out activitiesTrack site documents including CVs, training records, regulatory approvals, and essential correspondenceCoordinate logistics for investigator meetings, monitoring visits, and study materialsRegulatory & Compliance Support Assist with regulatory submissions and maintenance of regulatory filesEnsure documentation complies with ICH-GCP, SOPs, and applicable regulationsSupport audit and inspection readiness activitiesData & System Management Update and maintain clinical trial tracking tools and systems (eTMF, CTMS, SharePoint, etc.)Support data entry and reconciliation across clinical systemsRequired Qualifications Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field1–3 years of experience in clinical research or clinical trial operationsBasic understanding of clinical trial processes and ICH-GCP guidelinesExperience working with eTMF and CTMS systemsStrong organizational and documentation skillsExcellent written and verbal communication abilitiesPreferred Qualifications Experience in CRO or FSP environmentExposure to global clinical trialsExperience supporting Phase I–IV clinical studiesFamiliarity with sponsor-specific SOPs and processesAttention to detail and quality focusStrong coordination and follow-up skillsAbility to manage multiple tasks and timelinesCollaborative team playerProficiency in MS Office (Excel, Word, PowerPoint)Office-based / hybrid / remote (as applicable)May require occasional travel for investigator meetings or training#J-18808-Ljbffr