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Clinical Trial Associate

New Jersey All, NJ

Job Type: Clinical Job Number: JN -122019-26159 Region: New Jersey All

Job Description

Maintaining the Trial Master File (TMF) and assisting with site management, initiating the distribution, collection, handling, reviewing, tracking and archiving of essential documents throughout the lifecycle of clinical studies; this includes managing the filing indexes and maintaining current lists of correspondence; ensures completeness of, conducts regular audits of, organizes and archives clinical Trial Master File documents, including clinical study site documents, email correspondence, training materials and other study documents; participates in TMF or study audits as request and assists with responding to findings

Assists the study teams with site communications for various purposes-this includes feasibility/site identification activities and site updates

Performs study start-up activities which includes but is not limited to review of informed consents, development and review of study reference plans and manuals; distribute, collect and conduct quality review of clinical study site documents

Responsible for the submission of study documents to ethics committee and/or competent authorities; works as a liaison with review boards and independent ethics committees in the regulatory approval process

Assists with the creation and maintenance of study-specific documents, tools and materials and the procurement of study supplies

Provides study materials and supplies to the study sites and Clinical Research Associates (CRAs)

Assists with tracking of clinical study progress including the creation and maintenance of study related trackers and status reports

Participates in clinical team meetings coordinates teleconferences/webinar and assists with the preparation of agendas, minutes and tracking of action items

Prepares for and attends Investigator Meetings, as required

May participate in clinical vendor selection process, as required

Performs review of clinical data listings, as required

Under general supervision, manage third party vendors in the every-day conduct of a clinical trial (central lab, reading center, IRB)

May act as mentor and train less experienced CTAs

Maintains completion of company and study-specific trainings such as SOPs, policies, study plans and documents by due date

May participate and contribute to the implementation of process improvements to support study teams, department or the company (e.g. SOPs)

Education & Experience

Bachelor's Degree and a minimum of 4 - 6 years of CTA experience in clinical research is required

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