Clinical Research Associate

Location: Minnetonka, MN

Respicardia

This position is part of a multidisciplinary team working together with the Research and Development, Regulatory Affairs and in-house administrative staff to support ZOLL Respicardia clinical trials. This position is expected to help manage all sites and vendors (e.g., Core labs, Clinical Research Organization) in addition to being responsible for proactively coordinating all necessary activities related to the trial master file. The position works in conformance with GCP requirements and Company Standard Operating Procedures.

Job Summary:

As a key member of the Clinical Affairs team, this person is responsible for:

  • Organizing clinical development teams for clinical trials and clinical affairs projects.
  • Preparation of clinical trial documentation, IRB/EC submissions and approvals.
  • Process improvement, Standard Operating Procedures (SOP), work instructions and training guidelines
  • Reports to Director of Clinical Affairs and Biostatistics

Essential Functions:

  • Support and assist Clinical Study Management with clinical development teams for clinical trials.
  • In collaboration with Clinical Study Management, assist with clinical trial protocols and associated documents.
  • In collaboration with Clinical Study Management, define CRF specifications and define edit check specifications.
  • Assist clinical trial sites with IRB/EC submissions and approvals.
  • Final review of monitored CRFs.
  • Manage Investigator Initiated Study Process.
  • Coordinate Clinical and Scientific Affairs Steering Committee.
  • Lead or participate in department projects such as process improvement, Standard Operating Procedures (SOP), work instructions and training guidelines.
  • Support Scientific Affairs projects by assisting with creating and maintaining appropriate documentation, compliance with SOPs and training.
  • Participate in project meetings to give status updates to management.
  • Ensure clinical trials are performed in compliance with Good Clinical Practices to support data quality and audit readiness.
  • Any other duties as required.
  • Travel: 0 – 10%

Skill Requirements:

  • Excellent organizational skills and attention to detail
  • Customer Focus
  • Computer proficiency (MS Windows, MS Office Suite incl. Visio)
  • Knowledge of Good Clinical Practice (ISO 14155 and ICH E6).
  • Experience with clinical trial management systems preferred.
  • Process Management
  • Process Improvement identification and action
  • Independent Decision Making and Problem Solving

Education Requirements:

  • Bachelor's Degree and 5 years relevant experience in medical device clinical trials.

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990