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Clinical Trials Coordinator

2 months ago

Miami, United States Medix™ Full time

We are seeking a dedicated Clinical Trials Coordinator to advance their professional journey within our organization. As our team grows, we require an individual capable of overseeing clinical trials from initiation to completion. Medix™ provides ample opportunities for career advancement along with a competitive compensation and benefits package.

Essential Qualifications

  • Bachelor's Degree and/or a minimum of 3 years' experience in clinical research coordination within the industry
  • The ideal candidate is meticulous, dependable, and adept at managing multiple tasks in a dynamic, high-volume environment

Key Responsibilities

  • Facilitates and orchestrates daily activities of clinical trials, playing a pivotal role in the execution of the study
  • Develops, oversees, and maintains essential documentation for each trial
  • Participates in teleconferences and Investigator Meetings as directed by the research director
  • Thoroughly reviews and understands all study protocols, including study procedures, timelines, eligibility criteria, and confidentiality measures
  • Efficiently executes all assigned study tasks (e.g., scribing, VFQ, IOP, etc.)
  • Gathers updated medical histories, adverse events, and serious adverse events for timely reporting to the sponsor and IRB
  • Ensures that revised consent forms are properly implemented and signed
  • Acts as a secondary reviewer to guarantee the accuracy of the informed consent process
  • Collects data as mandated by the protocol and inputs information into the electronic data capture (EDC) system within the specified timeframe
  • Monitors data entry for accuracy and resolves any queries promptly
  • Responsible for acknowledging and reviewing all SUSAR/Safety Reports
  • Coordinates site monitoring visits and aids in the preparation of necessary documentation
  • Collaborates with monitors to implement required corrections to meet compliance and deadlines
  • Manages and maintains all regulatory documentation related to the study, including the protocol, investigator brochure, IRB documents, investigator disclosures, CVs, training records, and reporting instructions for the IRB and sponsor