Clinical Trial Assistant

CenExel•,

2d•$22 - $27•Remote

About The Position

The Clinical Trial Assistant (CTA) supports the planning, coordination, and execution of clinical research studies. This role ensures that clinical trials are conducted in compliance with regulatory requirements, study protocols, and internal procedures. The CTA works closely with clinical research associates (CRAs), study managers, investigators, and sponsors to maintain accurate documentation and facilitate smooth trial operations.

Requirements

1–2 years of experience in clinical research.
Knowledge of clinical research processes and regulations (e.g., ICH-GCP guidelines).
Working knowledge of CTMS (e.g. Clinical Conductor or similar).
Working knowledge of e-TMF or e-ISF systems (e.g. Florence or Veeva Vault).
Strong organizational and time management skills.
Attention to detail and accuracy in documentation.
Effective written and verbal communication skills.
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
Ability to manage multiple tasks and meet deadlines.
Must be able to effectively communicate verbally and in writing.

Nice To Haves

Bachelor’s degree in life sciences, healthcare, or a related field (preferred).

Responsibilities

Assists in the preparation, collection, and maintenance of clinical trial documentation (e.g., Trial Master File (TMF), Investigator Site Files (ISF)).
Tracks and manages study-related documents, ensuring completeness and compliance with regulatory standards (e.g., FDA, ICH-GCP).
Supports study start-up activities, including site selection, regulatory submissions, and ethics committee documentation.
Coordinates communication between study teams, sponsors, and investigational sites.
Maintains study tracking tools, including timelines, enrollment status, and site performance metrics.
Assists with scheduling meetings, preparing agendas, and documenting meeting minutes.
Supports monitoring visit logistics and follow-up actions.
Ensures proper filing, archiving, and version control of study documents.
Assists in safety reporting and tracking adverse events, as required.
Assists with financial tracking, including invoice review and matching agaisnt Clinical Trial Agreement, budgets and visit schedules / milestones.
Provides administrative support to the clinical operations team
Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.
Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.