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.
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