Hybrid Global Clinical Trials Coordinator

Actalent; Houston (TX); Hybrid; USD 51,000 - 73,000; Full time

Job summary

Actalent in Houston, TX is seeking a Clinical Trial Associate for a hybrid role (onsite 1–2 days weekly). You will support global clinical investigations, maintain inspection-ready documentation, and collaborate with Clinical Operations teams to keep studies on schedule.

Responsibilities include eTMF setup, CTMS data maintenance, site initiation support, IRB submissions, vendor coordination, and study dashboards.

Qualifications

• Minimum of 4+ years in clinical research or related role.
• Experience supporting study start-up and site management.
• Familiarity with FDA filing systems and regulatory documentation.
• Knowledge of ISO 14155 and Good Clinical Practice (GCP).
• Fluency in English, both written and spoken.
• Ability to travel up to 25%.
• Associates degree (AS) or Bachelors degree (BS).

Responsibilities

• Set up eTMF and maintain in-house Trial Master File filing.
• Support CTMS by tracking study contacts and activities.
• Assist in site start-up, NDA retrieval, and site selection trackers.
• Coordinate translations of study documents for global investigations.
• Prepare submission packages for IRBs/ECs and authorities.
• Prepare Site Initiation Visits documents and Investigator File materials.
• Ensure timely filing and inspection readiness of essential documents.
• Perform quality control of uploaded data and documentation.
• Support audits and inspections for clinical studies.
• Manage study-related logistics and supplier coordination.
• Coordinate meetings, newsletters, and site communications.
• Keep dashboards and trackers updated with study status.

Skills

eTMF

CTMS

Attention to detail

Documentation

Time management

Communication

Organizational skills

Education

Associate Degree or Bachelor’s

Tools

eTMF systems

CTMS

Job description

Actalent in Houston, TX is seeking a Clinical Trial Associate for a hybrid role (onsite 1–2 days weekly). You will support global clinical investigations, maintain inspection-ready documentation, and collaborate with Clinical Operations teams to keep studies on schedule.

Responsibilities include eTMF setup, CTMS data maintenance, site initiation support, IRB submissions, vendor coordination, and study dashboards.