Clinical Trial Associate - USA

OpenKrill; United States; On-site; USD 50,000 - 70,000; Full time

Job summary

Openkrill seeks a Clinical Trial Associate to manage essential study documents in the TMF and ensure sites receive required materials.

The CTA reports to the MCTA in the Western Region and will support the project team, assist with IRB/IEC submissions where applicable, and help organize study materials, templates, and training records across trials.

Qualifications

• Must have an Associate degree or equivalent experience.
• Minimum of two years of clinical research experience.
• Strong written and verbal communication skills; able to work in a team.

Responsibilities

• Provides administrative support to the project team.
• Assists the Project Manager with communications to the project team and sites.
• Assist in pre-identifying sites and in site feasibility activities.
• Collects initial essential documents from sites.
• Assist in regulatory submissions and IRB/IEC processes as applicable.
• Create study-specific documents and materials; maintain TMF/eTMF files.
• Maintain project trackers and training matrices; coordinate training.
• Procure and ship study materials and supplies to sites and CRAs.
• Prepare meeting minutes and facilitate internal and Client meetings.

Skills

Written communication

Verbal communication

Interpersonal skills

English language proficiency

ICH/GCP familiarity

FDA/MHRA/EMA regulations

Team collaboration

Multitasking

Education

Associate degree or equivalent experience

Tools

Veeva Vault

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 experiencePhysical requirementsUS: 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.