Clinical Trial Associate - USA

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

The Clinical Trial Associate (CTA) is responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File (TMF), ensuring that project- specific administrative documents are maintained, and sites are supplied with all required clinical materials and supplies.

CTA reports to the Managers, Clinical Trial Associates (MCTA) in the Western Region.

Duties and Responsibilities

• Provides administrative support to the project team
• Assists the Project Manager (PM) with written and verbal communications to the project team and sites
• As required, assist in pre-identifying sites
• As required, assist in site feasibility including providing feedback regarding site responses to the project team and the Client
• Collects (or assists with the collection of) initial essential documents from sites
• As applicable, assist the study team in implementation activities including preparation, collection of Regulatory and Essential Documents, facilitation of IRB/IEC submission and approval process. Submits the study to the central IRB (if applicable, North America only)
• Assists the PMs with the creation of study-specific documents and materials
• Maintains the study organizational charts
• Perform PI background check
• Creation of Investigator Site Files and customization of study-specific templates for sites and core documents, as applicable
• Maintains project-specific trackers, as applicable
• Responsible for uploading and assigning project-specific training documents in the Learning Management System (LMS) and maintaining the Project Team Training Matrix
• Procures and ships study materials and supplies to sites and Clinical Research Associates (CRAs)
• Assists sites with Annual/Continuing Review IRB Submissions (North America only)
• Assists the PM with the organization of meetings; attends internal and Client meetings
• Prepares and issues meeting minutes, including action items, under the direction of the PM
• Request translations, as required
• File documents into the TMF (eTMF) on behalf of CRAs and / or Study Team according to the TMF plan, as required
• Reviews and classifies documents submitted to the TMF by the study team for accuracy, completeness, and compliance with internal and Client quality standards to fulfill all federal and local regulations
• Ensures electronic TMF (eTMF) documents are named according to naming conventions specified in the eTMF Plan, and are equivalent to the original
• Files project management documents in the eTMF according to the eTMF Plan
• Assists the project team with reconciliation of the periodic TMF QC performed by the project team
• Assists in the close-out of projects by resolving a final QC of the TMF, identifying items and issues for review and/or follow-up by the CRAs and/or PM
• Upon request, project e-mail account is created and creates structure. Assists with filing (classification) of e-mails upon request
• Maintains expert knowledge of Veeva Vault for eTMF including system user support
• Other duties as assigned

Required Skills and Abilities

• Good written and verbal communication skills including good command of English language Excellent interpersonal and communication skills
• Awareness of ICH, GCP, and other pertinent constructs such as FDA, MHRA, EMA regulations and local guidelines
• Ability to work successfully in a matrixed team environment
• Dedication to quality and detail in all work tasks and deliverables
• Ability to prioritize and manage multiple tasks
• Working knowledge of computer systems, applications and operating systems

Education and Experience

• Associate degree or equivalent experience
• Requires a minimum of two years of clinical research experience

Physical requirements

US: Can tolerate prolonged periods of sitting at a desk and working on a computer

$50,000–$70,000 base salary, plus PTO and comprehensive benefits.