Clinical Trial Assistant – Contract to Hire

This is a fully remote position, open to applicants in New York.

📋 Description

• Assist Clinical Operations and study leadership with the daily coordination and administration of assigned clinical trials.

• Organize and coordinate study meetings.

• Develop agendas, presentation materials, meeting minutes, action items, and follow-up documentation.

• Maintain study trackers, action logs, metrics, dashboards, and additional tools utilized to monitor study progress and deliverables.

• Communicate with clinical trial sites regarding routine study activities and documentation.

• Keep current records of investigator and site information.

• Gather and organize data for site feasibility, site identification, and site selection.

• Assist in the preparation of study-specific training materials, investigator meetings, site initiation activities, and other study meetings.

• Monitor 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.

• Aid in study close-out, including collecting outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other necessary records.

• Prepare, review, route, and track study documents.

• Compile and maintain study reference materials and manuals.

• Ensure document version control and confirm that current approved materials are accessible.

• 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 gather essential regulatory and study documents, including Form FDA 1572s, Financial Disclosure Forms, investigator qualifications, licenses, and training documentation.

• Assist with clinical trial registry activities.

• Facilitate coordination and tracking of third-party vendors.

• Support Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities.

• Help in the development and revision of SOPs, templates, forms, work instructions, and Clinical Operations tools.

• Suggest improvements to study processes, trackers, templates, and workflows.

• Carry out other clinical trial support activities in line with assigned studies and respective training and experience.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare, business, or a related field, or a comparable 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 abilities.

• Capacity to manage multiple priorities, deadlines, documents, and study activities simultaneously.

• Keen attention to detail and dedication to accurate, complete documentation.

• Effective written and verbal communication skills.

• Ability to collaborate effectively with Sponsors, clinical sites, CRAs, vendors, and internal team members.

• Capability to work independently within assigned responsibilities and appropriately escalate questions, risks, or issues.

• Proficiency in Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.

• Candidates must be proficient in English.

• Candidates must be located in a workable time zone for the study team.

• Preferred experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site.

• Preferred experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms.

• Preferred experience in maintaining study trackers, meeting minutes, action logs, and clinical trial documentation.

• Preferred experience in supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out.

• Preferred experience coordinating or supporting third-party vendors.

• Preferred experience in supporting rare disease, pediatric, or other complex clinical development programs.

🏝️ Benefits

• Contract-to-hire opportunity.

• Remote work arrangement.

• Full-time schedule.

• Opportunity to support clinical trials for a global language and technology solutions company’s client.