Senior Clinical Trial Associate

Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visit reports, etc. Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs Performs quality checks on the study TMF with oversight of study Clinical Operations Lead (COL) Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc. Coordinates and tracks clinical trial equipment and supplies Coordinates and tracks shipments of drug supply Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation May support and participate in departmental/cross-functional process improvement initiatives Supports the trial team to produce and distribute study newsletters Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc. Serves as point of contact for 1 or more low to medium complexity vendors with oversight of study Clinical Operations Lead Liaises with clinical trial sites as required Requirements Bachelor’s degree in life sciences or healthcare related field 4+ years’ experience in a clinical research related position Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook Solid understanding of the responsibilities and needs of other functions in a clinical trial Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment Ability to maintain confidentiality of proprietary information Proficient written and verbal communication skills Position may require some travel Core Competencies Demonstrates expertise in coordinating clinical trial documentation and maintaining inspection-ready Trial Master Files (TMF) in compliance with ICH-GCP and company SOPs. Proficient in managing vendor relationships, tracking clinical supplies, and supporting cross-functional initiatives within clinical research. Highest-signal resume keywords Clinical Trial Coordination Trial Master File (TMF) Management Vendor Invoice Review Document Preparation Strong Communication Skills ATS Optimization Keywords Hard Skills Clinical Research Document Management Quality Checks Data Tracking Process Improvement Soft Skills Independent Work Multitasking Confidentiality Maintenance Industry Keywords ICH-GCP Clinical Operations Trial Documentation Clinical Trial Sites Purchase Order (PO) Generation Tools & Technologies Excel Word PowerPoint Outlook #J-18808-Ljbffr