Clinical Research Associate II

Location: Remote, CA

Cardiac Management Solutions

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 purpose

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 ICH-GCP, and with applicable regulatory requirements.

Duties and responsibilities

  • Oversee site activity of selected trials to ensure all trial deliverable are met according to timelines, budget, quality standards and operational best practices
  • Identify/assess 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 essential documents 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 ICH-GCP requirements
  • Responsible for subject safety and proper site conduct throughout the trial
  • Maintains all relevant documentation and communications as part of study files
  • 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, ICH-GCP, Regulations, per the applicable regulatory requirements to the Project Manager and the Investigator
  • Coordinates clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required
  • Assists with the development and facilitation of clinical documents including informed consent forms, case report forms, study manuals, Standard Operating Procedures, and other clinical materials to ensure compliance with regulatory, IRB/EC, and company policies
  • 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
  • Assist in Study Team Startup, Management and Closeout
    • Database UAT (User Acceptance Testing) in electronic data system
    • Project Specific Set up of Clinical Trial Management System (CTMS)
    • Project specific set up, maintenance and archiving of the Trial Master File (TMF)
    • Setup/Manage CRA Teams’ implementation of Site-Specific Files (SSF) for ongoing audit readiness
  • 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
  • May travel to study sites based on project needs
  • Performs other duties as assigned by Project Management
  • Up to 40% travel

Qualifications

·An academic degree in Life Sciences or equivalent education/experience.

·At least 2 year monitoring experience in clinical research

  • At least 2 year 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 trial sites (start-up to close-out)

·Ability to work with minimal supervision once given instructions

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.

Physical requirements

While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

Supervisory responsibility

None

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

 Equal Opportunity Employer – Disability and Veteran