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Clinical Research Coordinator I

2 months ago

Gainesville, Florida, United States InsideHigherEd Full time
Clinical Research Coordinator I Job Description

We are seeking a highly motivated and detail-oriented Clinical Research Coordinator I to join our team at the University of Florida. The successful candidate will be responsible for coordinating clinical research activities, including study activation, subject recruitment, and data management.

Key Responsibilities:
  • Coordinate research studies and special projects as directed
  • Assist Principal Investigator with all study-related duties
  • Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
  • Screen, recruit and enroll research participants
  • Document investigational product (drug/device) accountability
  • Review and provide laboratory results for physician input on abnormalities or referral for additional work-up
  • Monitoring of subjects enrolled in trials in accordance with medical and health management standards, study protocols, and GCP/ICH guidelines
  • Participate in direct subject care via the collection of vital signs, ECGs, FibroScans, concomitant medication, adverse events, as well as other protocol required procedures
  • Access medical records from Epic for medical history as well as results on diagnostic studies, labs, surgical pathology, clinic notes, etc.
  • Collect, process and ship laboratory specimens
  • Conduct ongoing internal auditing of research charts and data of clinical trials
  • Work in conjunction with the regulatory and compliance office in study activation, which includes feasibility review, organization of IDS, ancillary services, site qualification visit, and site Initiation Visit (SIV)
  • Facilitate pre-study, site qualification, study initiation and monitoring visits
  • Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Develop Case Report Forms/source documents
  • Participate in promoting Human Subjects Protections within Clinical Research areas
  • Maintain study source documents
  • Apply good clinical practice (GCP) standards and regulatory compliance (including ICH guidelines and the Code of Federal Regulations
  • Educate subjects and family on protocol, study intervention, study drug, dosing tools, etc.
Requirements:
  • Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience
  • Prior or current clinical trial experience
  • Phlebotomy and sample processing experience
  • Knowledge of Regulatory guidelines and IRB submissions
  • Data entry Experience (InForm, Medidata, Rave, REDCap, Connect, Oracle, and Oncore)
  • Clinical Research Coordinator Certification

Please note that the salary range for this position is $44,000 - $53,000 annually.