Hybrid Clinical Trial Operations Specialist

Actalent; United States; Hybrid; USD 51,000 - 73,000; Full time

Benefits offered by this job

Medical dental vision

401(k) plan

Life insurance

PTO

Job summary

Actalent is seeking a Clinical Trial Associate for a hybrid role based in Houston, TX. You will support global clinical investigations, ensure inspection-ready documentation, and collaborate with Clinical Operations teams to meet timelines.

The position involves managing eTMF, CTMS, site start-up, and regulatory submissions with a focus on attention to detail and proactive workflow. The role requires 4+ years in clinical research, English fluency, and willingness to travel up to 25%.

Qualifications

• Experience supporting clinical studies and site management.
• Familiarity with FDA filing systems and regulatory docs.
• Knowledge of ISO 14155 and GCP guidelines.
• Ability to keep inspection-ready files and trackers.
• Travel up to 25% for site visits.

Responsibilities

• Set up and maintain eTMF and filing per SOPs and GCP.
• Support CTMS activities: contacts, trackers, and dashboards.
• Assist start-up, site selection, and confidentiality agreements.
• Coordinate translations of study documents for global trials.
• Prepare submissions for IRBs and regulatory authorities.

Skills

Clinical trials

CTMS usage

eTMF management

Regulatory knowledge

English fluency

Documentation control

Education

AS or BS degree

Tools

CTMS

eTMF platform

IRB portals

Job description

Actalent is seeking a Clinical Trial Associate for a hybrid role based in Houston, TX. You will support global clinical investigations, ensure inspection-ready documentation, and collaborate with Clinical Operations teams to meet timelines.

The position involves managing eTMF, CTMS, site start-up, and regulatory submissions with a focus on attention to detail and proactive workflow. The role requires 4+ years in clinical research, English fluency, and willingness to travel up to 25%.