Clinical Trial Operations Specialist - TMF & Site Support

Linical; Florida; On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

PTO

Comprehensive benefits

Job summary

Linical is seeking a Clinical Trial Associate (CTA) to support TMF documentation, site materials, and study logistics. You will collect, review, and archive essential documents, maintain trackers, and assist with IRB submissions and meeting coordination.

Responsibilities include training, eTMF naming, procurement, and liaising with PMs and sites to ensure compliance and timely delivery of study materials. A strong eye for detail and English proficiency are required.

Qualifications

• Associate degree or equivalent experience required.
• Minimum of two years of clinical research experience.
• Knowledge of ICH, GCP, and FDA/MHRA/EMA regulations.
• Excellent written and verbal English communication.
• Ability to work in a matrixed team.

Responsibilities

• Provides administrative support to the project team.
• Assists the PM with communications to the project team and sites.
• Assist in pre-identifying sites as required.
• Assist in site feasibility including feedback on site responses.
• Collects initial essential documents from sites.
• Assist in regulatory and essential documents submission and IRB/IEC submissions.
• Assist in creating study-specific documents and materials.
• Maintains study organizational charts.
• Perform PI background checks.
• Create Investigator Site Files and templates.
• Maintain project-specific trackers.
• Upload and assign training documents in LMS.
• Procure and ship study materials to sites and CRAs.
• Assist with Annual/Continuing Review IRB submissions (NA).
• Organize meetings; take minutes and action items.
• Request translations as required.
• File documents into TMF/eTMF per plan.
• Review TMF submissions for accuracy and compliance.
• Ensure eTMF documents are correctly named.
• File project management documents in the eTMF.
• Assist TMF QC reconciliations.
• Close-out projects by final QC and follow-up.
• Create project email structure and filing as needed.
• Maintain expert knowledge of Veeva Vault for eTMF.

Skills

Communication

English proficiency

Regulatory knowledge

Teamwork

Multi-tasking

Tech literacy

Education

Associate degree or equivalent experience

Two years clinical research experience

Job description

Linical is seeking a Clinical Trial Associate (CTA) to support TMF documentation, site materials, and study logistics. You will collect, review, and archive essential documents, maintain trackers, and assist with IRB submissions and meeting coordination.

Responsibilities include training, eTMF naming, procurement, and liaising with PMs and sites to ensure compliance and timely delivery of study materials. A strong eye for detail and English proficiency are required.