Clinical Trial Associate 

The Clinical Trial Associate (CTA) will be tasked with providing clinical trial coordination support, along with implementing the clinical operational plans in accordance with regulatory guidelines and ICH/GCP standards. Primary responsibility of the CTA is to help plan, execute and manage of all the company’s clinical trials in conjunction with the Clinical Trial Manager.

  

 

 

Specific responsibilities include:

  • Support the clinical study teams in the execution of clinical studies and clinical projects

  • Organizes, manages and in cases where this is outsourced, oversees the Trial Master File to maintain up-to-date regulatory documentation for all research sites

  • Oversees reconciliation and transmittal of essential documentation to the TMF and produces reports, as needed

  • Provides information for, reconciles and processes investigator payments for subject visits and pass-through expenses according to contractual budgets and schedules

  • Maintains screening & enrollment tracking database to assist management with subject recruitment strategies and projections

  • Manage study trackers and provide metrics as needed.

  • Assists with the preparation and distribution of meeting agendas and minutes; actively participates in team meetings

  • Prepares, handles, and distributes clinical trial supplies as needed (study binders, mini-protocols, inclusion/exclusion cards, advertising materials, etc.)

  • May act as a central contact for the study team for designated project communications, correspondence, and associated documentation

  • Performs administrative tasks to support team members with clinical trial execution, as needed

  • Assists the project team with the planning, preparation, and on-site support of investigators and other meetings

  • Assist with invoice and budget management.

  • Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections.

  • Prepare and maintain assigned program files.

    Qualifications:

  • Must be proficient in MS Office Suite (Word, Excel, PowerPoint)

  • Must be organized with attention to detail

  • Must be able to develop and maintain Excel tracking databases

  • Must have excellent written and oral communication skills

  • Must have basic working knowledge of clinical operations

  • Must be familiar with ICH-GCP Guidelines

  • Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed.

  • Ability to work independently and within a team structure.

  • Superior listening and communication skills.

  • Positive approach.