Clinical Research Coordinator I

4 days ago

Gainesville, Florida, United States InsideHigherEd Full time
Job Description

The Department of Medicine, Division of Gastroenterology is seeking a full-time Clinical Research Coordinator I to perform all Clinical Research Coordinator (CRC) Core responsibilities and additional responsibilities detailed below.

Key Responsibilities
  • Coordinates research studies and special projects as directed
  • Assists Principal Investigator with all study-related duties
  • Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
  • Screens, recruits and enrolls research participants
  • Documents investigational product (drug/device) accountability
  • Reviews and provides laboratory results for physician input on abnormalities or referral for additional work-up
  • Monitors 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.
  • Collects, processes and ships laboratory specimens
  • Conducts 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)
  • Facilitates pre-study, site qualification, study initiation and monitoring visits
  • Acts as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals
  • Develops Case Report Forms/source documents
  • Participates in promoting Human Subjects Protections within Clinical Research areas
  • Maintains study source documents
  • Applies good clinical practice (GCP) standards and regulatory compliance (including ICH guidelines and the Code of Federal Regulations
  • Edits 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

  • Clinical Research Coordinator I

    1 week ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Position Title:Clinical Research Coordinator IJob Type: Staff Full-TimeDepartment: Community DentistryRole Overview:The Clinical Research Coordinator I is responsible for managing and facilitating the execution of research initiatives within the Principal Investigator's laboratory. This role encompasses a variety of essential tasks including:Regulatory...

  • Gastroenterology Clinical Research Specialist

    1 week ago

    Gainesville, Florida, United States Wake Research Full time

    Job OverviewCompany Overview:M3 Wake Research is a leading network of top-tier investigational sites dedicated to fulfilling the clinical research requirements of global biopharmaceutical, biotechnology, medical device, pharmaceutical, and clinical research organizations (CROs). With nearly 30 owned and managed research facilities nationwide, M3 Wake...

  • Gastroenterology Clinical Research Specialist

    2 weeks ago

    Gainesville, Florida, United States Wake Research Full time

    Job OverviewCompany Overview:M3 Wake Research is a prominent network of investigational sites dedicated to fulfilling the clinical research requirements of global biopharmaceutical, biotechnology, medical device, pharmaceutical, and clinical research organizations (CROs). With nearly 30 owned and managed research sites nationwide, M3 Wake Research stands as...

  • Gastroenterology Clinical Research Specialist

    1 week ago

    Gainesville, Florida, United States Wake Research Full time

    Job OverviewWake Research, a prominent entity in the clinical research landscape, is seeking a Clinical Research Physician to enhance our team. This role is pivotal in steering clinical trials and ensuring adherence to regulatory standards while fostering innovation in patient care.Company BackgroundWake Research operates a comprehensive network of...

  • Research Project Coordinator

    2 weeks ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Clinical Research Coordinator IJob Overview:The Clinical Research Coordinator I plays a pivotal role in managing and executing research initiatives within the Principal Investigator's laboratory. This position involves a variety of responsibilities, including:Key Responsibilities:Project Management: Oversee the implementation of research projects, ensuring...

  • Senior Clinical Research Coordinator

    2 weeks ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Position Title: Clinical Research Coordinator IIIJob Type: Full-Time StaffDepartment: Health Outcomes and Biomedical InformaticsOverview: The Department of Health Outcomes and Biomedical Informatics is on the lookout for a motivated and skilled individual to take on the role of Clinical Research Coordinator III. This position is pivotal in our mission to...

  • Clinical Research Coordinator II

    2 weeks ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Coordinator II to join our team at InsideHigherEd. The successful candidate will work closely with our Manager of Clinical Research to coordinate all aspects of our research component.Key ResponsibilitiesSelect and recruit study participants to enroll in various studies and protocolsParticipate in...

  • Research Administrator I

    3 hours ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Research Administrator I to join our team at InsideHigherEd. The successful candidate will be responsible for coordinating proposal submissions, managing agreements, and providing post-award support to our research faculty.Key ResponsibilitiesProposal Preparation and SubmissionCoordinate with...

  • Clinical Services Coordinator I

    2 weeks ago

    Gainesville, Florida, United States University of Florida Full time

    Position Title: Clinical Services Coordinator I Position Overview: The Clinical Services Coordinator I plays a crucial role in the healthcare delivery process by ensuring that patients are accurately registered and scheduled for their appointments. This position is responsible for validating patient accounts prior to their visits, which is essential for...

  • Clinical Services Coordinator I

    2 weeks ago

    Gainesville, Florida, United States University of Florida Full time

    Position Title: Clinical Services Coordinator I Position Overview: The Clinical Services Coordinator I plays a vital role in ensuring that patients are accurately registered and scheduled for their appointments. This position is responsible for validating patient accounts prior to their visits, ensuring a seamless experience. Key Responsibilities: 1....

  • Clinical Research Nurse Coordinator

    1 week ago

    Gainesville, Florida, United States Northeast Georgia Health System Full time

    Job Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryThe individual in this role will be responsible for the organization, execution, and assessment of clinical research trials. This encompasses all stages of...

  • Clinical Research Nurse Coordinator

    1 week ago

    Gainesville, Florida, United States Northeast Georgia Health System Full time

    Job Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Position OverviewAccountable for the coordination, execution, and assessment of clinical research trials. This encompasses all stages of research: Initiation, Execution,...

  • Clinical Research Nurse Coordinator

    2 weeks ago

    Gainesville, Florida, United States Northeast Georgia Health System Full time

    Job Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryAccountable for the coordination, execution, and assessment of clinical research trials. This encompasses all stages of research: Study Initiation, Execution,...

  • Clinical Study Coordinator

    1 week ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Clinical Research Coordinator IJob No: 532574Work Type: Staff Full-TimeCategories: Allied Health, Health Care Administration/SupportDepartment: DN-COMMUNITY DENTISTRYJob OverviewThe Clinical Research Coordinator I plays a vital role in managing and facilitating research initiatives within the principal investigator's laboratory. This position involves the...

  • Clinical Research Nurse Coordinator

    2 weeks ago

    Gainesville, Florida, United States Northeast Georgia Health System Full time

    Job Category:Nursing - Registered NurseWork Shift/Schedule:8 Hr Morning - AfternoonNortheast Georgia Health System is dedicated to enhancing the health of our communities.About the Role:Job SummaryThe Research Nurse Coordinator is accountable for the organization, execution, and assessment of clinical research trials. This encompasses all stages of research:...

  • Clinical Services Coordinator I

    2 weeks ago

    Gainesville, Florida, United States University of Florida Full time

    Classification Title:Clinical Service Representative IJob Overview:The Clinical Service Representative I plays a crucial role in ensuring that patients are accurately registered and scheduled for their appointments. This position involves validating patient accounts prior to visits and initiating financial agreements for new patients. The representative is...

  • Clinical Research Project Manager

    2 weeks ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Senior Clinical Research CoordinatorJob No: 530950Work Type: Staff Full-TimeLocation: Main CampusCategories: Allied Health, Social/Behavioral Science, Grant or Research Administration, Health Care Administration/SupportDepartment: MD-HOBI-GENERALJob OverviewThe Department of Health Outcomes and Biomedical Informatics is on the lookout for a motivated and...

  • Advanced Clinical Research Specialist

    1 week ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Senior Clinical Research CoordinatorJob No: 530950Work Type: Staff Full-TimeLocation: Main CampusCategories: Allied Health, Social/Behavioral Science, Grant or Research Administration, Health Care Administration/SupportDepartment: MD-HOBI-GENERALJob OverviewThe Department of Health Outcomes and Biomedical Informatics is on the lookout for a dedicated and...

  • Clinical Care Coordinator I

    1 week ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Clinical Case Manager IJob No: 532573Work Type: Staff Full-TimeLocation: CollierCategories: Allied Health, Veteran's Preference Eligible, Health Care Administration/SupportDepartment: DN-COMMUNITY DENTISTRYJob OverviewClassification Title:Clinical Case Manager IRole Summary:This position focuses on community-based education and case management.Key...

  • Research Funding Coordinator II

    2 weeks ago

    Gainesville, Florida, United States InsideHigherEd Full time

    Research Administrator IIJob No: 532640Work Type: Staff Full-TimeLocation: Main CampusCategories: Grant or Research AdministrationDepartment: MD-PSYCHIATRYJob OverviewClassification Title:Research Administrator I or IIPosition Summary:Pre-Award Management: This role involves the supervision of the creation and submission of sponsored program proposals,...