Lead Clinical Research Coordinator

COMPANY DESCRIPTION Charter Research is a highly experienced and quickly growing clinical research company, based inFlorida and Illinois, that is looking to add to our team to help us fulfill our mission of discovering future medicines.

Our company is privately owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors.

Above all, we are a team, and we are seeking the right team member to add to our foundation inOrlando.

POSITION OVERVIEW The Lead Clinical Research Coordinator is responsible for overseeing the day-to-day operations of clinical trials.

The Lead Clinical Research Coordinator plans and directs clinical research studies working directly with patients to guide them successfully through the clinical trial process and is responsible for managing clinical trial performance.

Team Members in this role are expected to follow Good Clinical Practice (GCP) in the conduct of clinical investigations and to collect, record, and maintain source and sponsor documentation.

RESPONSIBILITIES Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator.Adhere strictly to the study protocols, including all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and other requirements.Educate patients and their family members regarding the clinical trials process and the details of the specific study in which theyre participating.Assess eligibility of potential patients and oversee patient enrollment to ensure that informed consent is properly obtained and documented.Coordinate and conduct patient visits (drawing blood, collecting vital signs, performing ECGs, and processing specimens) and assure all procedures are conducted in compliance with the clinical trial protocol and Good Clinical Practice (GCP).Communicate clinical trial issues to Sponsor and/or Contract Research Organization (CRO), Principal Investigator, and Clinic Manager.Keep all source documentation up-to-date and in compliance with ALCOA-C standards.Communicate closely with the sponsors Clinical Research Associate (CRA) to facilitate the sponsor monitoring and data maintenance process.Complete all monitor and sponsor queries in a timely manner.Track enrollment status of patients and ensure timely communication with patients regarding their study participation.Prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.Provides training to new team members and reviews their work for accuracy.

Identifies and communicates opportunities to improve existing processes.

Assists in the coordination of team meetings and presents information and updates as needed.Communicates complex clinical trial information in a clear manner and applies tact and d...