Sr Clinical Trial Assistant

Connect Life Sciences; Cambridge (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Connect Life Sciences is seeking an experienced clinical documents and study operations professional in Cambridge, MA. The role focuses on setting up and reconciling the eTMF, maintaining study trackers, and handling study documents across multiple programs.

The position also involves tracking PO and vendor invoices, coordinating sample shipments to labs, managing feasibility data, and supporting regulatory filings including FDA Form 1572.

Qualifications

• Bachelor's in life sciences or related field.
• At least 3 years of relevant industry experience.

Responsibilities

• Set up, maintain, and reconcile the electronic Trial Master File (eTMF).
• 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.

Education

Bachelor's in life sciences or related field

At least 3 years of relevant industry experience

Job description

• 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.

Qualifications

• Bachelor's in life sciences or a related field
• At least 3 years of relevant industry experience