Clinical Trial Assistant - Contract to Hire

TransPerfect•New York, NY

20h•Remote

About The Position

TransPerfect is sourcing this role on behalf of a contract research organization (CRO), and candidates will apply through TransPerfect. The Clinical Trial Assistant supports assigned clinical trials by providing day-to-day coordination and administrative support to Clinical Operations and study leadership. The position is full-time and structured as a 12-month contract-to-hire role. It is remote and open to English-speaking candidates based in the United States or internationally, provided they are in a workable time zone for the study team. The role spans study coordination and communication; study start-up, conduct, and close-out; document management and Trial Master File (TMF) support; vendor coordination; and quality and process improvement. The assistant coordinates meetings and follow-up, maintains study trackers and documentation, communicates with sites as directed, tracks trial milestones and deliverables, and escalates risks or delays. They help ensure study records are organized, current, complete, and stored in the designated repositories, and support audits, inspections, and process improvements.

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 simultaneously.
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 appropriately escalate questions, risks, or issues.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint, Outlook, and Teams.
English-speaking; must be located 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 a 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

Provide day-to-day coordination and administrative support to Clinical Operations and study leadership for assigned clinical trials.
Schedule and coordinate study meetings; prepare agendas and presentation materials; and document minutes, action items, and follow-up.
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 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 other deliverables; identify overdue or potentially delayed activities and escalate risks, issues, or delays.
Support study close-out, including tracking 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 study 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, missing or incomplete document tracking, 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.
Compile and track information for clinical trial 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 assigned study needs and the individual's training and experience.