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 designated clinical trials.

• Organize and schedule study meetings.

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

• Maintain various study trackers, action logs, metrics, dashboards, and additional tools for tracking study progress.

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

• Keep updated investigator and site information, including contact details, site status, and necessary documentation.

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

• Assist with the creation of study-specific training materials, investigator meetings, site initiation activities, and other study-related meetings.

• Monitor start-up and site activation, enrollment, monitoring visits, pending documents, milestones, and deliverables.

• Identify overdue or potentially delayed activities and escalate risks, issues, or delays as necessary.

• Aid in study close-out processes, including essential documents, site close-out activities, investigational product documentation, financial disclosures, and required records.

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

• Compile and manage study reference materials and manuals.

• Ensure document version control and availability of current approved materials.

• Organize study folders, shared workspaces, and electronic repositories.

• Support Trial Master File (TMF) activities, including document collection, filing, quality review, reconciliation, and following up on missing documents.

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

• Assist with clinical trial registry activities.

• Help coordinate and track third-party vendors.

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

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

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

• Perform additional clinical trial support activities in line with assigned studies and relevant 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 knowledge of clinical trial conduct and Good Clinical Practice (GCP).

• Strong organizational capabilities.

• Ability to handle multiple priorities, deadlines, documents, and study activities concurrently.

• Keen attention to detail and a commitment to producing accurate and complete documentation.

• Proficient written and verbal communication skills.

• Capacity to work collaboratively with Sponsors, clinical sites, CRAs, vendors, and internal team members.

• Ability to operate independently within assigned responsibilities, while appropriately escalating questions, risks, or issues.

• Proficiency in 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.

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

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

• Preferred: Experience 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 in coordinating or supporting third-party vendors.

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

🏝️ Benefits

• Contract-to-hire opportunity.

• Full-time position.

• Remote work arrangement.

• Opportunity to collaborate with a global leader in language and technology solutions.

• Potential to transition from a 12-month contract to permanent employment.