Clinical Quality Management Associate at Pharmaceutical Research Associates, Inc. in Raleigh, North Carolina

Posted in Admin - Clerical 5 days ago.





Job Description:

Pharmaceutical Research Associates, Inc.

Clinical Quality Management Associate

US-Remote


Job ID: 2021-84148
Type: US
# of Openings: 1
Category: Clinical Trial Support

Vertex Pharmaceuticals

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.



Responsibilities

The Clinical Quality Management Associate is a detail oriented profession, who supports the CQM department in areas of process, training and compliance, SUSAR distribution, and ensuring that studies are inspection ready.

  • Distributes SUSAR reports to investigators
  • Runs and distributes compliance reports
  • Assists in vendor oversight
  • Performs QC of documents and participates in revisions
  • Routes documentation for appropriate signage
  • Collects, organizes and prepares regulatory documentation for transfer to Trial Master File and assists with tracking of document under guidance
  • Helps to develop and maintain tracking tools for event investigation, training, SUSAR distribution and inspection readiness
  • Coordinates meetings, prepares agendas and takes minutes
  • Supports internal training initiatives for new hires and ongoing training for study teams.
  • Provides Administrative training support to users with curriculum and user group creation, training items and user assignment.
  • Responsible for ongoing maintenance of the GCO component of learning portals
  • Manages the collection and retention of training signature logs
  • Coordinates tracking of external training activities
  • Produces metric reports for event investigations
  • Performs other duties as assigned


Qualifications

  • Strong communication (written and verbal) skills to be able to interact with internal Vertex groups as well as external groups
  • Strong attention to detail
  • Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
  • Exhibits ability to ‘multi-task’ effectively
  • Ability to interact well with various team members and provide value added support to proj
  • Displays ability to independently solve routine problems following standard policies/procedures
  • B.S. or Advanced Degree (or equivalent degree/experience in the opinion of the Hiring Manager)
  • Minimum of 1-4 years of relevant work experience


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

PI149856436
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