Clinical Trials Coordinator

2 weeks ago

Beverly, Massachusetts, United States MDC Associates Full time
Job Overview

As a Clinical Research Associate, you will act as a crucial intermediary between clinical trials and comprehensive clinical data. Your role will involve spearheading the identification, assessment, and establishment of clinical study sites for in-vitro diagnostic medical devices.

This position offers a unique opportunity to significantly contribute to the swift and safe availability of cutting-edge diagnostic tests and devices to healthcare professionals and their patients. At MDC Associates, this is our core mission, and we are seeking individuals who can help us address the increasing demand for enhanced clinical tools.

Key Responsibilities
  • Identify, assess, and lead the execution and coordination of clinical studies.
  • Act as the primary contact for study participants throughout IVD medical device studies.
  • Conduct site monitoring visits and compile reports for study initiation, monitoring, and closure.
  • Draft clinical study protocols, supporting plans, and procedures, including informed consent forms, monitoring plans, and data collection forms in collaboration with study project teams.
  • Assist with submissions to the Institutional Review Board (IRB).
  • Manage trial master files, budgets, and agreements for assigned studies.
  • Train site personnel on protocol requirements, source documentation, and case report form completion.
  • Assist in the development of study databases for managing clinical data.
  • Monitor and analyze clinical study data and report on performance metrics.
About MDC Associates

For over three decades, MDC has supported innovators and entrepreneurs in bringing in vitro diagnostics (IVD) and medical devices to market, positively impacting the lives of millions of patients globally. Our mission is to continue aiding these innovators by leveraging our expertise in Regulatory Affairs, Quality Systems, Training, and other consulting services to facilitate the launch of new advancements that enhance and safeguard the health of our global and local communities.

Qualifications
  • Bachelor's degree in healthcare or a related scientific discipline or equivalent education.
  • Minimum of 2 years of relevant clinical study experience in the medical devices or pharmaceuticals sectors (experience with in-vitro diagnostic devices is preferred).
  • ACPR or similar certifications are advantageous but not mandatory.
  • Proven experience in applying clinical research regulatory requirements, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and HIPAA guidelines.
  • Strong understanding of U.S. Food and Drug Administration (FDA) regulations and guidance on clinical studies.
  • Solid working knowledge of IRB guidelines and the Common Rule.
  • Ability to manage competing priorities and drive initiatives without compromising quality.
  • Excellent communication skills to convey complex information and present options/solutions to diverse stakeholders and teams.
  • Exceptional organizational, problem-solving, and time-management abilities.
  • Proficiency in Microsoft Office Suite.
  • Meticulous attention to detail and accuracy in work.
Travel Requirements

Estimated travel of 20-50% includes:

  • Visits to study sites and clinical study management.
  • Meetings with regulatory agencies.
  • Participation in scientific, medical, and industry meetings and conferences.
  • International travel as necessary.
Equal Opportunity Employer

MDC Associates, Inc. is an Equal Opportunity Employer committed to fostering a diverse workforce. We do not discriminate against any worker or job applicant based on race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, gender reassignment, non-job-related mental or physical disability, genetic information, veteran status, military service, or any other category protected under law.

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