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Clinical Trial Associate

Duties

The Clinical Trial Associate  position is a key support role within Clinical Operations, undertaking essential coordination activities for the study team.

 

Assist with study coordination activities, including:

Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
File, track and maintain TMF
Maintain internal/external contact list
Conduct electronic documentation and records management
Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
Ensure timely study entry and updates to ClinicalTrials.gov
Prepare investigator meeting materials
Design and prepare study related materials for the training of internal and external staff

 

 

Assist with study conduct activities, including:

Startup:

Facilitate CDA and contract execution. Assist with regulatory package review

Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study CRA or Study Lead

Contact and identification of investigators for participation in clinical studies

 

Enrollment and Maintenance:

Issues identification, resolution, and escalation

Track site payments and vendor invoices

 

Closure:

Conduct study closure activities (sites, reconciliation activities, filing & archiving)
Track, collate clinical trial documentation related to CSR appendices

Skills

2-5 years of clinical research experience, preferrably within biotech or pharm industry.

Education

Bachelor’s Degree desired and/or equivalent experience in Life Sciences, Nursing, or related disciplines

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