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Clinical Research Project Coordinator

2 months ago

Hamtramck, Michigan, United States Henry Ford Health System Full time
Position Overview

The Clinical Research Project Coordinator plays a pivotal role in overseeing clinical research initiatives within the surgical domain. This position operates with a high degree of autonomy, ensuring that all projects adhere to regulatory standards and institutional protocols.

Key Responsibilities
  • Coordinate clinical research activities while ensuring compliance with federal regulations.
  • Provide essential technical assistance to Principal Investigators throughout the research process.
  • Evaluate protocol-specific needs and implement quality assurance strategies to maintain compliance among physicians, patients, and clinical staff.
  • Extract and synthesize medical data from diverse sources within patient medical records.
  • Document and report any adverse events to the medical monitor, regulatory agencies, and other relevant authorities.
  • Facilitate external audits and monitoring visits, acting as the primary liaison between the institution and research sponsors.
  • Serve as a valuable resource for both departmental and system-wide inquiries.
QualificationsEducation and Experience:
  • A Bachelor's degree in Clinical Research, Biology, Chemistry, Nursing, or a related field is required.
  • A minimum of two years of relevant experience is preferred.
  • Prior experience in a coordinator role is advantageous.
  • Strong organizational, analytical, and problem-solving skills are essential.
  • Exceptional verbal and written communication skills at a professional level are necessary.
Certifications:
  • Preferred certifications include SOCRA or ACRP and IATA certification.
  • Experience in clinical research is beneficial but not mandatory.