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Clinical Trials Coordinator

2 months ago

Wellesley, Massachusetts, United States The Vascular Care Group Full time
Job Overview

Position: Clinical Research Coordinator

Company: The Vascular Care Group

Summary

The Vascular Care Group is at the forefront of managing clinical trials for a distinguished network of vascular surgeons. Our trials encompass both device and pharmaceutical studies, ranging from initial pilot studies to post-market registry evaluations. We leverage an advanced clinical trial management system that facilitates the electronic storage of all subject and regulatory documentation, thereby enhancing remote trial management and ensuring compliance with regulatory standards.

This position plays a crucial role in the initiation of clinical trials and the coordination of patient enrollment across our network.

Flexibility to travel between various sites is essential; primary work locations will include multiple sites, with the majority of responsibilities performed in person.

Key Responsibilities

  • Coordinate and lead weekly meetings with clinic and outpatient staff to review schedules and identify potential participants.
  • Evaluate patient records to determine eligibility for specific clinical research protocols.
  • Monitor patients for any adverse reactions related to study treatments, procedures, or medications, and communicate findings to the appropriate clinical staff.
  • Manage device logistics, including transportation or shipping of devices for procedures as required.
  • Assist in the preparation of necessary regulatory documentation for new trials and participate in training sessions for upcoming studies.
  • Collect and enter source data into the Clinical Trial Management System (CTMS) and Electronic Data Capture (EDC) systems, addressing queries and collaborating with monitors to resolve issues.
  • Support the onboarding and training of additional personnel to assist with various clinical trials.
  • Ensure adherence to all Institutional Review Board (IRB), FDA, and other regulatory requirements.
  • Contribute to the development of electronic templates within the CTMS for new trials to facilitate eSource documentation.
  • Travel regularly to various offices to support trial initiation and patient enrollment activities.

Qualifications

  • Bachelor's Degree in biological sciences, health sciences, social sciences, or a related medical field, or an equivalent combination of education and experience.
  • Clinical experience in a surgical specialty is required; experience in vascular surgery is preferred.
  • A minimum of one year of experience in a clinical research role or familiarity with clinical research processes is preferred.
  • Proficiency in medical terminology is essential.
  • Strong computer skills are necessary, as the role involves extensive use of Electronic Medical Records and EDC systems.
  • Attention to detail, proficiency with technology, and the ability to work independently while embracing challenges are critical attributes for success in this role.