Clinical Research Coordinator - 255355

ResponsibilitiesCoordinate all aspects of participant care from screening through study completion as defined by theprotocol and PI delegation.Ensure and document that the informed consent process has occurred properly according to the Code ofFederal Regulations (45 CFR part 46).Assist in the process of maintaining and updating each study participant’s source records, includingcollection of medical history, assessment of eligibility and documentation of all study related proceduresand relevant information.Promptly report adverse events, protocol deviations and unanticipated problems involving risk to humansubjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations(21 CFR 312), with assistance as applicable.Ensure thorough, individualized, protocol-based study subject education on all study processes includingbut not limited to informed consent, study participation obligations, appropriate use of investigationalproduct (IP), IP side effects and safety, communication with study staff and research rights.Provide timely and accurate exchange of participant information with the PI and research team as itpertains to study conduct and patient safety.Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protectparticipant confidentiality at all times.Dispense, administer and instruct participants on proper use of the investigational product (IP) inaccordance with the protocol, coordinator’s scope of practice and at the direction of the PI, withassistance as needed.Collaborate with the USRC clinical team. Participate in trial implementation, and ensure compliance withthe study protocol by our clinical partners, with assistance as needed.Perform accurate and timely data collection, source documentation, and entry into the USRC databasesand sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries andsponsor requests in a timely manner.Aid in the coordination of long-term storage of research records in accordance with contractualrequirements, with direction from the Director of Clinical Research.Assist in the preparation of and attendance during site initiation meetings, monitoring visits, audit visits orregulatory authority inspections.Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstratecompliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: FormFDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutionalreview board (IRB) related documents, IND reports delegation of authority (DOA), study specificenrollment logs, monitoring reports, with assistance as needed.Assists in the coordination of efforts of internal and external resources (industry partners, clinical researchorganizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollmentgoals and trial plan execution.Fosters a patient-care culture that emphasizes patient safety and quality in all aspects.Responsible for the patient stipend automated payment process including registration into the system andprocessing payments per the USRC policy and ongoing maintenance of payments during the trial.Adheres to the USRC Research quality assurance program guidelines.Travel to Investigator Meetings or similar research related meetings is required.Travel may be required between dialysis facilities or nephrology practices within the community.Develops a working knowledge of current clinical research practice standards and regulatoryrequirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice(GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and TransportationAssociation (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures andcertifications.May provide training and oversight of Clinical Research Coordinators and/or Research Assistants.Actively promotes GUEST customer service standards; develop effective relationships at all levels of theorganization.Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures.Participate in staff meetings as required.Regular and reliable attendance is required for the job.Required Skills2 years min of CRNeeds someone who has been in a patient facing research role or exp as a MA or EMT or PhlebAbility to support at least 3 studies at once. Studies are industry funded and IIT at Toledo locationPreferred SkillsNephrologyBachelorsSchedule/ShiftMonday–Friday, 9AM–5PM. Occasionally may need to start early (5AM). Some metro travel to satellite locations within 10 miles