Clinical Trial Assistant – Contract to Hire

Job not on LinkedIn

🔥 5 minutes ago

🗽 New York – Remote

🗽 New York – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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TransPerfect

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

Consulting • Legal • Marketing

TransPerfect is a global language and technology company that provides translation, localization, interpretation, and content services combined with software and AI-powered tools such as the GlobalLink translation management platform. It offers multilingual marketing, legal and life‑sciences regulatory support, contact center/BPO services, multimedia localization, and solutions for website, software and app globalization. TransPerfect serves large enterprise and Fortune 500 clients across dozens of industries and supports content in 200+ languages.

📋 Description

• Support Clinical Operations and study leadership with day-to-day coordination and administration of assigned clinical trials • Schedule and coordinate study meetings • Prepare agendas, presentation materials, minutes, action items, and follow-up documentation • Maintain study trackers, action logs, metrics, dashboards, and other tools used to monitor study progress and deliverables • Communicate with clinical trial sites about routine study activities and documentation • Maintain current investigator and site information • Collect and organize information for site feasibility, site identification, and site selection • Support study-specific training materials, investigator meetings, site initiation activities, and other study meetings • Track start-up and site activation, enrollment, monitoring visits, outstanding documents, milestones, and other deliverables • Identify overdue or potentially delayed activities and escalate risks, issues, or delays • Support study close-out, including outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other required records • Prepare, review, route, and track study documents • Compile and maintain study reference materials and manuals • Maintain document version control and ensure current approved materials are available • Maintain study folders, shared workspaces, and electronic repositories • Support Trial Master File activities, including document collection, filing, quality review, reconciliation, and follow-up on missing or incomplete documents • Track and collect essential regulatory and study documents, including Form FDA 1572s, Financial Disclosure Forms, investigator qualifications, licenses, and training documentation • Support clinical trial registry activities • Assist with third-party vendor coordination and tracking • Support Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities • Help develop and revise SOPs, templates, forms, work instructions, and Clinical Operations tools • Recommend improvements to study processes, trackers, templates, and workflows • Perform other clinical trial support activities consistent with assigned studies and training and experience

🎯 Requirements

• Bachelor's degree in life sciences, healthcare, business, or a related field, or an equivalent combination of education and relevant experience • Approximately 3 years of experience in clinical research, clinical operations, the pharmaceutical or biotechnology industry, or a CRO • General understanding of clinical trial conduct and Good Clinical Practice (GCP) • Strong organizational skills • Ability to manage multiple priorities, deadlines, documents, and study activities at once • Strong attention to detail and commitment to accurate, complete documentation • Effective written and verbal communication skills • Ability to work collaboratively with Sponsors, clinical sites, CRAs, vendors, and internal team members • Ability to work independently within assigned responsibilities and escalate questions, risks, or issues appropriately • Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams • Candidates must be English-speaking • Candidates must be in a workable time zone for the study team • Experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site is preferred • Experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms is preferred • Experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation is preferred • Experience supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out is preferred • Experience coordinating or supporting third-party vendors is preferred • Experience supporting rare disease, pediatric, or other complex clinical development programs is a plus

🏖️ Benefits

• Contract-to-hire opportunity • Remote work • Full-time schedule • Opportunity to support clinical trials for a global language and technology solutions company’s client

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