Provide administrative and operational support for clinical trials, including the maintenance of trial master files and regulatory documentation. Coordinate study activities, manage clinical data in CTMS and EDC systems, and ensure compliance with GCP and SOPs.
Requirements summary
An associate's degree or higher in life sciences or healthcare is preferred, along with 1-3 years of related experience. Candidates should possess strong organizational skills and a willingness to learn clinical research regulations.
Respicardia At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives.
Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Respicardia division of ZOLL Medical Corporation is focused on helping people with central sleep apnea get access to a therapy to restore a more normal breathing pattern during sleep and give them better quality of life.
We develop breakthrough therapies for an impactful disease that is severely underdiagnosed and often untreated.
As we continue to grow, those who join our team will work alongside motivated people who care about others, put patients first and are dedicated to high-quality and innovative solutions.
Job Type On Site Job Summary 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.
Essential Functions 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.
Required/Preferred Education and Experience 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
Knowledge, Skills and Abilities
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 Travel Requirements Minimal travel required (up to ~10%, as needed) Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Standing - Occasionally Walking - Occasionally Sitting - Frequently Talking - Occasionally Hearing - Frequently Repetitive Motions - Frequently ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The hourly pay rate for this position is: $28.00 to $32.00 Factors which may affect this rate include shift, geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com. Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.
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