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Clinical Research Coordinator 232566

2 months ago

Miami, United States Medix™ Full time

We are looking for a Clinical Research Coordinator ready to take the next step in their career. Our team is expanding and we are looking for someone who is able to manage trails from start up through close out. Our company offers a ton of room for growth and development as well as a competitive salary and benefits package.


Must haves

  • Bachelor’s Degree and/or 3 years’ experience as a clinical research coordinator with industry experience
  • Ideal candidate is detail oriented, reliable, and able to multitask in a fast-paced, high-volume work environment


Responsibilities

  • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study
  • Creates, manages, and maintains source documents for each trial
  • Attends teleconferences and Investigator Meetings as requested by research director
  • Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections
  • Efficiently completes all study tasks delegated to them (i.e., scribing, VFQ, IOP, etc.)
  • Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within required time frame
  • Assures that amended consent forms are appropriately implemented and signed
  • Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately
  • Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.
  • Oversees data and ensures that it is being entered correctly and resolves any queries issued within required time frame
  • Responsible for ensuring all SUSAR/Safety Reports are acknowledged and reviewed
  • Coordinates monitor site visits and assists with preparation of site visit documentation
  • Works with the monitor to make any corrections needed to meet requirements and deadlines as needed
  • Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor