Clinical Research Coord IApply now (https://secure.dc4.pageuppeople.com/apply/674/gateway/default.aspx?c=apply&lJobID=533369&lJobSourceTypeID=796&sLanguage=en-us) Job no: 533369 Work type: Staff Full-Time Location: Main Campus (Gainesville, FL) Categories: Health Care Administration/Support Department: 29051400 - MD-GASTROENTEROLOGY Classification Title:Clinical Research Coordinator IJob Description:The Department of Medicine, Division of Gastroenterology is seeking a full time Clinical Research Coordinator I. This position performs all Clinical Research Coordinator (CRC) Core responsibilities and additional responsibilities detailed below. The candidate must be able to function independently in a clinical research setting and responsible for the complete coordination of assigned clinical research activities. Displaying effective problem solving, writing, and communication skills are vital. Must have the ability to multi-task, working as part of a team or independently. The coordinator will work under the direct supervision of the GI Clinical Trials Manager.Essential Functions;
Clinical Research Trials Coordination
Coordinates research studies and special projects as directed Communicate with Principal Investigator to fully understand 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 Participates in direct subject care via the collection of vital signs, ECGs, FibroScans, concomitant medication, adverse events, as well as other protocol required procedures Accesses 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 Works 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 Participates 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.
Data Entry and Abstraction
Data entry into in EDC systems (RAVE, REDCap, Inform, etc.) Documents patient visits and procedures in UF’s OnCore Database Monitor and answer for data query delinquencies EPIC documentation
Regulatory/Clerical
Manage essential regulatory documents Filing source documents Manage HSP payment tracking and compliance with study budgets Maintain assigned databases/lab flowsheets for clinical care. Submit documents to regulatory authorities (e.g., IRB, FDA, etc.) and review/monitoring boards (i.e., DSMB, independent safety officer) Facilitate study closeout activities Schedule subject visits and procedures Retain records/archive documents after study closeoutExpected Salary:$44,000 - $53,000 AnnuallyMinimum 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.Preferred Qualifications: 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 CertificationSpecial Instructions to Applicants:In order to be considered, you must upload your resume.This position is time limited. Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required:YesAdvertised: 04 Oct 2024 Eastern Daylight TimeApplications close: 11 Oct 2024 Eastern Daylight Time