ZOLL

Clinical Research Associate

ID 2021-1986
Job Locations
US-MN-Minnetonka
Job Post Information* : Posted Date
3 weeks ago(10/5/2021 1:58 PM)
Category
Clinical
Job Post Information* : External Company URL
https://careers-zoll.icims.com/jobs/search

Company Name

ZOLL Respicardia

Overview

The Clinical Research Associate at ZOLL | Respicardia is part of a multidisciplinary team working together with the Clinical Affairs, Research and Development, Regulatory Affairs and in-house administrative staff to support Respicardia clinical trials.  This position is expected to provide support for the clinical team, trial sites and vendors in addition to other activities.  Specifically, this role will be 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.    

 

This full-time position reports to the Director of Clinical Operations and is located at our Minnetonka, MN facility.

Responsibilities

What you’ll do:

 

  • Primary responsibility will be to maintain, organize and update the electronic trial master files for clinical studies, including tracking and collection of documents that expire (e.g., IRB approval, curriculum vitae, medical licenses, etc.).
  • Tracking of regulatory documents required for investigational site activation.
  • Manage study supplies – track inventory and send to sites as needed.
  • Assist in collection of source documentation from sites related to adverse events and prepare material for adjudication by the clinical event committees.
  • Assist with data management and monitoring activities.
  • Assist in the creation and review of clinical trial and quality assurance documents.
  • Assist with device accountability records for investigational products.
  • Support regulatory submissions.
  • Interact with in-house study team, field clinical engineers, contract monitors and study sites as needed.
  • Other duties as assigned.
  • Available to travel (up to 10%).

Qualifications

What we’re looking for:

  • Minimum 2-year degree in life science or nursing background.
  • Minimum of 2 years of clinical research industry experience  (preferably medical device).
  • Strong organizational capabilities and problem-solving skills.
  • High attention to detail with excellent written and verbal communication skills.
  • Ability to produce accurate, high-quality work within tight timelines.
  • Knowledgeable of ICH GCP guidelines and regulations for clinical trial conduct.
  • Strong computer skills including MS Office products.

 

You take care of ZOLL | Respicardia and we'll take care of you!

 

ZOLL provides:

  • A casual work environment.
  • Competitive salaries.
  • A compensation structure that rewards contribution and hard work.

 

Benefits include:

  • 401(k)
  • Medical
  • Dental
  • Vision
  • Life
  • AD&D
  • FSA
  • STD/LTD
  • Paid Time Off 
  • Tuition assistance

 

You are qualified, interested and want to apply! Please visit us at:

 

https://careers-zoll.icims.com/jobs/1986/job 

 

ZOLL appreciates and values diversity. We are an equal opportunity employer and do not discriminate in hiring or employment on the basis of race, color, religion, national origin, citizenship, gender, gender identity, genetic information, marital status, sexual orientation, age, disability, veteran status, or any other characteristic protected by federal, state, or local law.

ADA: ZOLL will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

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