Clinical Trials Associate
About The Position
PRIMARY ROLE The CTA position is responsible for the support of the study team by creating, distributing, maintaining, and organizing study materials, tools and documents to ensure conduct of clinical trials is in compliance with protocol requirements, SOPs and ICH GCP Guidelines. Additional responsibilities include general administrative support to the Clinical Operations Department. WHAT YOU'LL DO Set up, organize, and maintain clinical study documentation, study level files and overall filing of study-specific documentation Assist in the start-up, management, close-out and reporting of assigned clinical studies Coordination of vendor supplies, tracking of inventory and study materials Participate in vendor User Acceptance Testing (UAT) activities Coordination of document translations, if required Assist in budget tracking and invoice review, data entry, and processing of investigator payments Liaise with the sites for specific requests (e.g., enrollment logs, missing documentation, meeting arrangements) Tracking and distribution of safety reports, as applicable Attend project meetings and generate meeting minutes Assist in the collection of ICH essential documents ensuring TMF is complete and appropriately maintained Assist in the preparation of project status reports for management review Maintain, update, and establish various databases and metrics to support Sponsor oversight responsibilities Ensure appropriate documentation of all identified site- and protocol-related issues Partner with Clinical Research Associate (CRA) to ensure completeness and accuracy of eISF and eTMF Facilitate posting and updates to Clinicaltrials.gov Other responsibilities as assigned
Requirements
- Bachelors degree in science, nursing, or equivalent
- Working knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
- Familiarity with pharmaceutical and medical terminology
- Experience with management and oversight of eTMF
- Experience with EDC and TMF platforms
- Excellent interpersonal, verbal, and written communication skills
- Strong attention to detail and organizational skills
- Strong knowledge of MS Office Suite, Outlook and Gmail
- Willingness to travel up to 10% overnight
Nice To Haves
- Risk-based monitoring (RBM) experience is a plus
- Working with trials conducted globally is a plus
Responsibilities
- Set up, organize, and maintain clinical study documentation, study level files and overall filing of study-specific documentation
- Assist in the start-up, management, close-out and reporting of assigned clinical studies
- Coordination of vendor supplies, tracking of inventory and study materials
- Participate in vendor User Acceptance Testing (UAT) activities
- Coordination of document translations, if required
- Assist in budget tracking and invoice review, data entry, and processing of investigator payments
- Liaise with the sites for specific requests (e.g., enrollment logs, missing documentation, meeting arrangements)
- Tracking and distribution of safety reports, as applicable
- Attend project meetings and generate meeting minutes
- Assist in the collection of ICH essential documents ensuring TMF is complete and appropriately maintained
- Assist in the preparation of project status reports for management review
- Maintain, update, and establish various databases and metrics to support Sponsor oversight responsibilities
- Ensure appropriate documentation of all identified site- and protocol-related issues
- Partner with Clinical Research Associate (CRA) to ensure completeness and accuracy of eISF and eTMF
- Facilitate posting and updates to Clinicaltrials.gov
- Other responsibilities as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
11-50 employees
