Clinical Trial Assistant - Contract to Hire

TransPerfect•New York, NY

3d•Remote

About The Position

TransPerfect is sourcing this role on behalf of a contract research organization (CRO); candidates apply through TransPerfect. The Clinical Trial Assistant supports assigned clinical trials with day-to-day coordination, administration, document management, regulatory and Trial Master File (TMF) activities, vendor coordination, and quality and process improvement. The role is a 12-month contract-to-hire position and is listed as full-time and remote. Candidates may be US-based or international if English-speaking, and must be in a workable time zone for the study team. One opening is available.

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 and 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.
English-speaking; must be in a workable time zone for the study team.

Nice To Haves

Experience supporting clinical trials at a CRO, Sponsor, biotechnology or pharmaceutical company, or clinical research site.
Experience with Trial Master File (TMF), Clinical Trial Management System (CTMS), electronic document management systems, or other clinical trial technology platforms.
Experience maintaining study trackers, meeting minutes, action logs, and clinical trial documentation.
Experience supporting informed consent form review, regulatory documentation, study start-up, monitoring, or study close-out.
Experience coordinating or supporting third-party vendors.
Experience supporting rare disease, pediatric, or other complex clinical development programs.

Responsibilities

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 tools used to monitor study progress and deliverables.
Communicate with clinical trial sites about routine study activities and documentation as directed by the Project Manager, CRA, or another designated team member.
Maintain current investigator and site information, including contact details, site status, and required documentation.
Collect and organize information for site feasibility, identification, and selection.
Support study-specific training materials, investigator meetings, site initiation activities, and other study meetings.
Track study start-up and site activation, enrollment, monitoring visits, outstanding documents, milestones, and deliverables; identify overdue or potentially delayed activities and escalate risks, issues, or delays.
Support study close-out, including tracking outstanding essential documents, site close-out activities, investigational product documentation, financial disclosures, and other required records.
Assist with preparing, reviewing, routing, and tracking study documents, including informed consent forms, study manuals, plans, forms, and templates.
Compile and maintain study reference materials and manuals, including regulatory, pharmacy, laboratory, monitoring, and other study-specific documentation; maintain document version control and help ensure current approved materials are available to team members and sites.
Maintain study folders, shared workspaces, and electronic repositories according to established filing structures and access requirements.
Support TMF document collection, filing, quality review, reconciliation, tracking of missing or incomplete documents, and follow-up with responsible parties.
Help ensure study documentation is complete, accurate, appropriately approved or executed, and stored in the designated repository.
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 by compiling and tracking information for registrations and updates, as directed.
Assist with third-party vendor coordination and tracking, including deliverables, documentation, meetings, action items, and follow-up.
Support preparation for Sponsor audits, regulatory inspections, TMF reviews, and other quality or compliance activities.
Help develop and revise SOPs, templates, forms, work instructions, and other Clinical Operations tools.
Recommend practical improvements to study processes, trackers, templates, and workflows to Clinical Operations leadership.
Perform other clinical trial support activities consistent with the needs of assigned studies and the individual's training and experience.