Clinical Trial Assistant (On Site)

Actalent

The Role

Overview

Assist with clinical trial start-up, coordination, documentation, and data management.

Key Responsibilities

  • data collection
  • doc review
  • study start-up
  • regulatory docs
  • supply tracking
  • cro coordination

Tasks

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

Requirements

  • tmf
  • ctms
  • excel
  • bsc lifesci
  • ivdr
  • 3‑5 yrs

What You Bring

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

Benefits

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

The Company

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

Utilities

Power

Automotive

Food and Beverage

Consumer Products

Industrial Goods

Manufacturing

Mechanical Engineering

Electrical Engineering

Systems and Software

Transmission Engineering

Distribution Engineering

Grid Automation

Transportation

Life Sciences

Pharmaceuticals

Biopharmaceuticals

Diagnostics

Academic Research

Medical Devices

Specialty Chemicals

Construction Management

Environmental

Architecture

Civil

Clinical Trial Assistant (On Site) at Actalent in Costa Mesa, CA