Clinical Project Coordinator

1 week ago

Lafayette, Louisiana, United States Cook Medical Full time
Job Title: Associate Clinical Project Manager

Overview

The Associate Clinical Project Manager plays a crucial role in supporting the management of daily operational and logistical activities of clinical studies. This position is responsible for assisting the clinical team in achieving milestones and deliverables, responding to site requests, facilitating site selection meetings, managing investigational device logistics, reviewing clinical documentation, and preparing studies for sponsor and site regulatory authority inspections.

Responsibilities

  • Collaborate with the clinical study team to ensure timely completion of study activities and compliance with quality system procedures, applicable standards, and clinical systems.
  • Assist in preparing clinical studies for audit-readiness by reviewing key documents and ensuring compliance with regulatory authority criteria.
  • Develop and maintain a working knowledge of best practices for quality review of documents uploaded to the Clinical Document Management System.
  • Provide support with query management and maintain a high level of accuracy and attention to detail.
  • Stay up-to-date with local and global regulatory requirements and standards, including FDA CFR, ISO 14155, GCP, and EU MDR.
  • Develop a general working knowledge of study-specific and general disease pathology.
  • Provide logistical support, including preparing and distributing study materials, coordinating internal meetings, and assisting with external clinical study meetings.
  • Attend study team meetings, take notes, and assist with generating meeting minutes.
  • Prepare for monitoring visits, including reviewing eTMF/CTMF documents.
  • Perform electronic data capture (EDC) administrative tasks as needed.
  • Assist the Clinical Project Manager with site and study-related documents and reports throughout the study lifecycle.
  • Manage clinical study insurance, if applicable.
  • Lead investigational device logistics locally and globally, including collaborating with stakeholders to develop Product Logistics Plans and maintaining documentation to support product accountability and disposition.
  • Facilitate site selection activities, including collaborating with the study team on assessment materials, scheduling meetings, and maintaining documentation to support site selection.
  • Facilitate review and selection of global/national/regional Principal Investigators, Steering Committee Members, and Proctors.
  • Maintain and ensure all clinical study documentation is in a state of audit-readiness.
  • Provide support for other clinical study activities as needed.

Qualifications

  • Associate's/Bachelor's degree in a scientific, health, or business-related field or equivalent work experience.
  • Previous experience in supporting research or medical device/drug clinical studies is preferred.
  • Strong work ethic and personal discipline.
  • Ability to work independently and apply judgment to prioritize tasks.
  • Excellent communication and teamwork skills.
  • Good computer skills and aptitude to learn new software platforms.
  • Experience with standard tools, including Microsoft Office.
  • High level of accuracy and attention to detail.
  • Strong organization and time management skills.
  • Excellent critical thinking, computer, written, and verbal communication skills.
  • Ability to attend occasional early morning or late evening teleconferences.
  • Willingness and ability to travel, as needed.
  • Positive attitude in challenging situations.

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