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.
Position Summary: Responsibility 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 Duties and Responsibilities:
- 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 reports
- Up to 70% travel
Supervisory Responsibilities: None.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Educations and/or Experience:
- An academic degree in Life Sciences
- At least 2 years monitoring experience in clinical research
- At least 2 years monitoring experience in medical device/pharmaceutical industry, preferred
- Cardiovascular device or pharmaceutical experience, preferred
- 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
- Demonstrated proficiency in implementing, monitoring, and management of clinical trials (start-up to close-out)
- Ability to work with minimal supervision once given instructions
Language Skills: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems and make appropriate judgment calls to insure the correct outcome.
Computer Skills: To perform this job successfully, an individual should be proficient in Microsoft Office Suite.
- 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to sit, walk, talk and hear. Employee may occasionally be required to lift and carry up to 25 pounds.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The noise level in the work environment is usually quiet.
Equal Opportunity Employer–minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity.