Clinical Trial Associate: Trials Logistics & Compliance

Actalent; Waltham (MA); Hybrid; USD 62,000 - 76,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability benefits

Paid time off

Job summary

Actalent in Waltham, MA is seeking a detail-oriented Clinical Trial Associate to support our clinical trials through coordination, logistics, tracking and administrative tasks. The role also involves assisting in departmental operations and special projects to improve study efficiency.

You will work with CTMs, CROs, vendors, and investigators, maintain Trial Master Files, enter data in CTMS, monitor enrollment and regulatory status, and help prepare meeting materials and CDAs.

Qualifications

• Bachelor's degree or equivalent with science/healthcare experience.
• 1–4 years of clinical research experience in pharma/CRO setting.
• Prior pharma/biotech/CRO experience required.

Responsibilities

• Coordinate logistics and tracking for clinical trials as part of the study team.
• Track budgets, invoices, POs, and accruals with CTM and Finance.
• Monitor study status, enrollment, regulatory docs, and site startup.
• Set up, file, maintain, reconcile, and archive Trial Master Files.
• Enter data into CTMS and support external access rights tracking.
• Interact with CROs, vendors, investigators, and monitors to resolve requests.
• Manage and track clinical and non-clinical supplies.
• Assist CTM with agendas and minutes for sub-team meetings.
• Coordinate CDAs/contracts with legal, finance, and Sr. Manager Ops.
• Support site advertisement review with CCC and special operations projects.

Skills

GCP/ICH Guidelines

Interpersonal skills

Organizational skills

Multi-tasking

Attention to detail

Teamwork

Education

Bachelor's degree or equivalent

Tools

CTMS

Job description

Actalent in Waltham, MA is seeking a detail-oriented Clinical Trial Associate to support our clinical trials through coordination, logistics, tracking and administrative tasks. The role also involves assisting in departmental operations and special projects to improve study efficiency.

You will work with CTMs, CROs, vendors, and investigators, maintain Trial Master Files, enter data in CTMS, monitor enrollment and regulatory status, and help prepare meeting materials and CDAs.