Clinical Trial Assistant (On Site)

Overview

Support study start-up, coordination, documentation, and data tasks for clinical trials.

Key Responsibilities

• stakeholder coordination
• supply tracking
• data collection
• study management
• document development
• regulatory prep

Tasks

-Coordinate with CROs, clinical sites, and vendors to ensure timely delivery of study milestones. -Track and manage clinical supplies, shipments, and site communications. -Participate in internal and external meetings, including meeting minutes and following up on action items. -Support data collection and query resolution. -Support study start-up, maintenance, and close-out activities across multiple clinical trials. -Assist in the development and review of study-related documents (e.g., protocols, ICFs, CRFs, monitoring plans). -Assist in the preparation of regulatory documents, ethics committee applications, and study start-up materials as needed.

Requirements

• ctms
• tmf
• excel
• bachelor's
• ivdr
• 3-5 years

What You Bring

-Experience with TMF systems and clinical trial management systems (CTMS). -Knowledge of clinical utility and performance evaluation studies. -Ability to work independently and collaboratively. -Bachelor’s degree in life sciences, healthcare or related field. -Proficient Excel, Word and PowerPoint skills. -Prior involvement in post-market surveillance activities. -Detail-oriented with a proactive approach to problem-solving. -Familiarity with IVD clinical trials and regulatory frameworks (IVDR, ISO 14155, GCP). -Strong understanding of clinical trial documentation and workflows. -3–5 years of experience as a CTA in biotech, diagnostics, or medical device industry. -Strong organizational and communication skills.

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Benefits

-Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Health Spending Account (HSA) -Transportation benefits -Critical Illness, Accident, and Hospital -Medical, dental & vision -Time Off/Leave (PTO, Vacation or Sick Leave) -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Short and long-term disability -Employee Assistance Program

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms