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 Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.
ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.
Job Summary
The Clinical Trial Assistant (CTA) provides administrative and logistical support to clinical trials. Their primary role is to support the Clinical Operations Department and its members, such as Clinical Research Coordinators, Clinical Research Project Managers, Director(s) and Investigator(s) with the daily tasks involved in operationalizing clinical trials. The tasks may include preparing trial documents, coordinating meetings and site visits, communicating with trial sites and vendors, managing trial data, and monitoring regulatory compliance.
Essential Functions

• Provide support to the clinical research team to ensure that the trial is conducted efficiently and in compliance with regulatory guidelines and department SOP’s.
• Responsible for performing administrative tasks, coordinating activities, and creating, maintaining, and organizing trial documents (i.e. trial protocols, informed consent forms, case report forms, and regulatory submissions)
• Responsible for organizing and coordinating trial meetings and site visits. May schedule meetings with external vendors, regulatory authorities, investigative sites and internal Clinical Operations or other interdepartmental team members.
• Responsible for communicating with trial sites, vendors, and other stakeholders to ensure that trial activities are conducted according to the study protocol and regulatory guidelines. May provide support for site staff, answer questions, and ensure that trial data is accurately collected and reported.
• Responsible for data entry and management, ensuring the trial data is accurately recorded and reported. May use electronic data capture (EDC) systems to enter data, perform quality checks, and resolve data discrepancies.
• Coordinate clinical trials by identifying subjects, developing recruitment and retention strategies, obtaining informed consent, screening, and enrolling trial subjects.
• Schedule subjects for trial visits; ensure participants complete questionnaires, collect medical history, and perform study procedures according to the trial protocol.
• Document adverse events and protocol deviations in electronic medical record and trial records as per protocol.
• Maintain data collection forms for effective data collection, entry, and analysis.
• Maintain subject data and address trial specific data queries promptly.
• Provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
• Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
• Support the Clinical Operations teams with ongoing conduct of studies, as needed.
• Set up, organize, and maintain clinical trial documentation, including preparation for internal/external audits, final reconciliation, and archival.
• Process Data Collection Forms, log in, track, and perform quality control as appropriate for the study.
• Coordinate ordering, dispensation and tracking of trial materials, such as CRFs, diary cards, lab supplies, binders, printed forms and drug or device supplies.
• Assist project teams with trial progress tracking by updating the Clinical Trial Management System (CTMS).
• Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• Contact clinical sites for specific requests, such as enrollment updates, missing documentation, meeting arrangements, etc.
• Other duties as assigned.

Required/Preferred Education and Experience

• High School Diploma required
• less than 1 year of related experience or equivalent combination of education and work experience preferred
• Clinical research experience preferred

Knowledge, Skills and Abilities

• Excellent attention to detail to ensure that trial documents are accurate and complete, and that data is collected and reported accurately.
• Strong organizational skills to manage multiple tasks and ensure that trial activities are conducted efficiently.
• Excellent communication and interpersonal skills to effectively communicate with trial sites, vendors, and other stakeholders.
• Able to work well in a team environment and be able to build and maintain positive relationships.
• Time management and multitasking abilities to effectively manage multiple tasks and ensure that trial activities are conducted on time.
• Able to prioritize tasks and manage their workload to ensure that trial timelines are met.
• Proficiency in computer software, such as Microsoft Office and electronic data capture (EDC) systems.
• Professional use of the English language, both written and oral.
• Ability to work with minimal supervision once given instructions.

Preferred Languages

• English - Intermediate

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 - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.