Clinical Trial Assistant

ZOLL Medical•Minnetonka, MN

2d•Onsite

About The Position

This position is responsible for providing administrative, operational, and coordination support for clinical trials within the Clinical Operations team. The role works collaboratively with Clinical Research Associates, Project Managers, Regulatory Affairs, and other cross-functional partners, as well as external stakeholders such as investigative sites, vendors, and contract research organizations. The position supports the execution of clinical studies by maintaining trial documentation, assisting with trial master files, coordinating study activities, and ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and company standard operating procedures. Responsibilities include document management, data entry, communication with sites and vendors, and logistical support for study conduct. This role serves as a foundational opportunity to gain experience in clinical research operations and trial management.

Requirements

Strong organizational skills with the ability to manage multiple tasks and priorities
Excellent attention to detail and commitment to data accuracy and quality
Effective communication and interpersonal skills for collaboration with internal teams and external stakeholders
Basic knowledge or willingness to learn GCP and clinical research regulations
Proficiency in Microsoft Office and ability to learn clinical systems such as CTMS and EDC
Strong time management and problem-solving skills
Ability to work independently with guidance and as part of a team

Nice To Haves

Associate’s degree or higher in life sciences, healthcare, or a related discipline preferred
1-3 years of related experience or equivalent combination of education and experience preferred
Exposure to clinical research or healthcare environment is a plus

Responsibilities

Provide administrative and operational support to the clinical research team to ensure studies are conducted efficiently and in compliance with regulatory guidelines, GCP, and Standard Operating Procedures (SOPs).
Maintain, organize, and update clinical trial documentation, including trial master files, regulatory documents, protocols, informed consent forms, and case report forms.
Track document expirations and follow up with investigational sites and clinical trial team members to obtain updated documentation.
Assist in the preparation, review, and quality control of study-related documents.
Enter, manage, and verify clinical trial data in systems such as Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC), ensuring accuracy and completeness.
Manage user access to clinical trial systems such as CTMS, electronic Trial Master File (eTMF), EDC, etc.
Perform data quality checks and assist with resolving discrepancies and data queries.
Support trial logistics by managing study supplies, tracking inventory, coordinating shipments, and maintaining device or investigational product accountability records.
Track regulatory approvals (e.g., IRB) and assist with regulatory submission processes.
Assist with audit and inspection readiness, including document organization, reconciliation, and archival.
Support monitoring activities, including preparation for monitoring visits, follow-up activities, and potential co-monitoring support.
Track vendor invoices, site payments, and study-related financial activities as needed.
Manage investigational sites payments.
Provide general administrative support to the Clinical Operations team and assist with project tracking and reporting.