Note: The job is a remote job and is open to candidates in USA. Connect Life Sciences is seeking a Senior Clinical Trial Assistant to support the operational and regulatory administration of clinical studies. The role maintains eTMF records and study trackers, coordinates vendors and biological sample shipments, supports site feasibility and ClinicalTrials.gov activities, and assists with study meetings and regulatory submissions.
Responsibilities
- Set up, maintain, and reconcile the electronic Trial Master File (eTMF) while supporting audit and inspection readiness
- Develop and maintain study management trackers, spreadsheets, and filing systems across multiple programs
- Track purchase orders, vendor invoices, study agreements, and contract routing
- Coordinate biological sample shipments to central and reference laboratories
- Manage site feasibility data, route document approval forms, request liability insurance, and support ClinicalTrials.gov registry activities
- Assist in planning internal and external study meetings, including managing agendas and minutes
- Provide required documentation (such as FDA Form 1572) to Regulatory Affairs for submissions
Skills
- Bachelor's in life sciences or a related field
- At least 3 years of relevant industry experience
- Oncology experience (Phase I-III)
- Global trials
- Clinical software (eTMF, CTMS, etc.)
Benefits
- Remote work
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