Reference #: R12877
CMSAt 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 SummaryResponsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Ensure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. Identify investigational sites, set up, initiate, monitor and close down the clinical trial.Essential Functions
Identify/select suitable investigators who will be responsible for the conduct of the trial at the trial site
Act as the main line of communication between the sponsor and the investigator
Facilitate investigator contract and budget as required
Set up the trial sites, ensuring that all research staff have adequate qualifications and that facilities, investigational products and resources remain adequate throughout
Train the site staff to trial-specific industry standards
Establish relationships and communicate regularly with investigative site staff and investigators
Work with trial sites to develop a subject recruitment plan and assist with subject recruitment and retention initiatives
Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis
Verify that the investigator follows the approved protocol, clinical objectives and all GCP/ICH procedures
Responsible for subject safety and proper site conduct throughout the trial
Verify that source data/documents and other trial records are accurate, complete, and maintained
Ensure adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol
Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator
Write visit reports
Track, manage and report on trial site status
Attend and participate in team meetings to provide status updates and facilitate information sharing
File and collate trial documentation and reports
Ensure all unused trial supplies are accounted for
Close down trial sites on completion of the trial
Participate in data reviews
Archive study documentation and correspondence
Assist with audit preparation and final study reportsRequired/Preferred Education and Experience
Bachelor's Degree in Life Science
At least 2 years experience in clinical research
At least 2 years experience in medical device/pharmaceutical industry, preferred
Cardiovascular device or pharmaceutical experience, preferredKnowledge, Skills and Abilities
Well-versed in medical terminology and ICH/GCP guidelines
Knowledge of legal and regulatory landscape concerning clinical research
Professional use of the English language, both written and oral
Excellent organizational skills with attention to detail
Demonstra ed proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out)
Ability to work with minimal supervision once given instructionsTravel Requirements
70% of travelPhysical Demands
While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms.Working Conditions
This position is generally performed in a typical office environment that is usually quiet. Employee is expected to work collaboratively with team members, as well as able to work independently with limited supervision. Work will require significant computer and telephone work.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.ZOLL LifeVest is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.