Clinical Trial Associate

Clinical Trial AssociateThe Clinical Trial Associate (CTA) supports clinical study teams in the execution and oversight of clinical trials under the direction of the Vice President, Development Operations, with day-to-day guidance from the assigned Study Lead. The CTA plays a key role in study start-up, ongoing trial execution, and close-out activities, with a primary focus on document management, trial tracking, and operational support.This role contributes to the maintenance of inspection-ready trial documentation and systems, including the Trial Master File (TMF/eTMF) and Clinical Trial Management System (CTMS), in compliance with applicable regulatory requirements (GCP/ICH), internal SOPs, and company standards.All activities are conducted in accordance with company policies, SOPs, and corporate values.Position ResponsibilitiesClinical Trial SupportSupport study start-up activities, including site feasibility, investigator onboarding, and collection of regulatory and essential documentsAssist with site management activities throughout the trial lifecycle, from start-up through close-outCommunicate with clinical sites and vendors, as appropriate, to support timely collection of required documentationSupport investigational product tracking activities, including inventory documentation, shipment tracking, and reconciliationTrial Documentation & SystemsMaintain accurate, complete, and inspection-ready Trial Master Files (electronic or paper)Support ongoing maintenance of the Clinical Trial Management System (CTMS), ensuring data accuracy and timelinessReview, file, and track clinical trial documentation in accordance with SOPs and regulatory requirementsAssist with quality control (QC) checks of study, country, and site-level documentation and support issue resolutionStudy Tracking & ReportingMaintain study trackers (e.g., regulatory submissions, site start-up timelines, protocol issue logs)Track study progress and generate routine status reports and metrics as requestedAssist with review of monitoring visit reports (initiation, routine monitoring, and close-out)Meetings & Cross-Functional CollaborationCoordinate and support internal and external study meetings, including preparation of agendas, meeting minutes, and action item trackingCollaborate with cross-functional teams, CROs, and vendors to support routine study operationsProvide general administrative and operational support to Development Operations team as neededCompliance & InspectionsSupport preparation for and follow-up on audits and regulatory inspections, as applicableAssist with review of informed consent documents, case report forms, and other study-related materialsEducation and ExperienceBachelor's degree (BS/BA) or equivalent preferredMinimum of 1–3 years of experience supporting clinical trials, preferably in a pharmaceutical, biotechnology, or CRO environmentTechnical Skills & Core CompetenciesFoundational knowledge of FDA and/or EMA regulations, ICH guidelines, and GCP requirementsBasic understanding of clinical trial documentation, filing structures, and operational workflowsWorking knowledge of clinical systems such as eTMF, CTMS, and EDC platformsAbility to manage multiple tasks and priorities in a fast-paced clinical development environmentStrong attention to detail and organizational skillsProficiency in Microsoft Office applications (Word, Excel, PowerPoint)Effective written, verbal, and interpersonal communication skillsAbility to work collaboratively across functions with appropriate supervision and guidanceProposed Compensation Range: 80,000 - 90,000