Clinical Trial Assistant

We are currently looking for a Clinical Trial Assistant (CTA) who will be responsible for providing support to the study team. This includes creating, distributing, maintaining, and organizing study materials, tools, and documents to ensure clinical trials comply with protocol requirements, SOPs, and ICH GCP Guidelines. In addition, the CTA will be responsible for providing general administrative support to the Clinical Operations Department.

DUTIES AND 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. Coordinate vendor supplies and track 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 collecting 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.

Qualifications

At least 3 years of industry experience or a Bachelor's 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 Risk-based monitoring (RBM) experience is a plus Working with trials conducted globally is a plus 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

Based on the primary location, the expected salary range for this position is $60,000-80,000 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for the company offered benefits.

Job Identifier: #4542