In-House Clinical Research Associate

Responsibilities

• Support study start-up, execution, maintenance, and close-out activities for assigned clinical trials.
• Aid in investigator/site identification, feasibility, and recruitment activities.
• Develop and maintain the study document version tracker to ensure document control and version accuracy.
• Upload study documents in the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• Track and maintain: Subject enrollment, Bioanalytic sample inventory, shipments, and receipt, database queries and resolution.
• Support CRAs and CTMs with study management activities, including vendor oversight, Investigator meeting planning, scheduling study team meetings to include agenda and meeting minutes.
• Coordinate with CRAs to review, maintain, and reconcile essential regulatory and study documents to ensure inspection readiness and compliance with ICH-GCP, SOPs, and applicable regulations.
• Perform routine TMF quality control reviews and coordinate reconciliation activities with field CRAs to ensure inspection readiness and document completeness.
• Supports field CRA(s) and investigational sites with regulatory submissions, IRB/IEC communications, and study-related documentation requirements.
• Serve as a point of contact for investigational sites regarding study questions, documentation, timelines, and operational support as needed.
• Manage and track subject travel reimbursement.
• Cover documents for site activation, prepare Investigational Site Green Light form for CTM sign off.
• Assist in the preparation and maintenance of study operational documents, including study plans, monitoring guidelines, site manuals, templates, and training materials.
• Review informed consent forms and essential documents for completeness, quality, and compliance.
• Collaborate with cross-functional teams and vendors to support study deliverables and project goals.
• Identify and escalate study risks, issues, and out-of-scope activities to study manager as appropriate.
• Ensure study activities are conducted in compliance with study protocols, Clinical Management Plans, SOPs, and applicable regulatory requirements.
• Support inspection and audit readiness activities as needed.
• Supports study budget tracking and invoice reconciliation activities as requested.
• Perform ongoing eTMF maintenance activities including document filing, QC review, reconciliation, tracking of missing documents, and follow-up with study teams and investigational sites to ensure TMF completeness and inspection readiness.
• Supports preparation and collection of study documentation and data required for safety reviews as applicable.
• Proactively identifies risks, developing and implementing mitigation plans as applicable.
• May assist in developing policies and procedures (SOPs).

Qualifications

• Excellent communication and collaboration skills with a team-oriented approach.
• Experience with eTMF, CTMS and EDC, (MS Project or Smart sheets timelines desired).
• CRO/vendor management experience is preferred.
• Experience in Ophthalmology and/or advanced therapy studies in Phases 1-3 desired.