Clinical Research Coordinator III

3 weeks ago

Gainesville, United States University of Florida Full time

Classification Title:

Clinical Research Coordinator III - Cardiovascular Surgery

Job Description:

Manage ongoing clinical research trials within the Division of Cardiovascular Surgery to ensure trial protocol compliance, subject safety, and fiscal compliance.

Coordination of Protocol Subjects

1. Perform subject screening and consent for clinical protocols under direction of Principal Investigator and Clinical Research Manager.

2. Schedule subject diagnostic testing procedures and follow-up clinic appointments, attend clinic study visits, collect baseline and follow-up data from the medical record, document findings in appropriate source records and case report forms.

3. Serve as patient resource and educator for information regarding the study or clinical symptoms.

4. Communicate with nursing staff and OR staff about patient care according to protocols. Assist with operating room protocol requirements where appropriate.

5. Maintain knowledge base of Good Clinical Practice Guidelines and Federal Code of Regulations regarding clinical trial conduct. Coordination and maintenance of HIPAA Compliance.

6. Report and follow up adverse events and serious adverse events, after discussion with Principal Investigator, to Sponsor and Investigational Review Board as required by protocol.

7. Travel to and attend Sponsor-hosted Investigator meetings to stay abreast of updates pertaining to the research trials.

8. Assist Clinical Research Manager with training of lower level research coordinators as needed.

Facilitate Post-Award Billing Compliance

1. Develop participant tracking logs that reflect the billing plan.

2. Work with OR business team to ensure proper billing for investigational devices and procedures.

3 Perform EPIC billing review multiple times each week to ensure proper billing compliance and timely release of Shands bills to 3rd party payers and/or patients.

4. Manage Human Subjects Payments for the trials to ensure that payments are in compliance with the approved IRB protocol, Informed Consent, and Institution policy.

5. Track all sponsor payments. Work with sponsors to reconcile any discrepancies between received payments and actual amounts owed.

Maintain Regulatory Compliance per Good Clinical Practice Guidelines, the Federal Code of Regulations, and UF policy

1. Organize and maintain regulatory files for clinical studies performed. Obtain medical licenses, CVs, and training documentation for Division study personnel. Work with other UF departments to obtain necessary documentation for other UF investigators working with the Division of Cardiovascular Surgery.

2. Collect and maintain Shands lab certifications.

3. Design case report forms and source documents for clinical protocols where required.

4. Coordinate efforts of Investigational Pharmacist and maintain site records for Good Clinical Practice and sponsor guidelines.

5. Draft Informed Consent Forms. Ensure subject injury language within the ICF matches the FLA issued by the Office of Clinical Research. Obtain sponsor and IRB approval. Update as necessary when study changes are made. Inform patients regarding any study updates and re-consent as needed.

6. Prepare and submit IRB submissions throughout the course of each trial (e.g. initial and final reviews, study amendments, continuing reviews, pertinent sponsor correspondence, DSMB reports, etc.)

7. Report adverse events (AEs) and serious adverse events (SAEs) to the IRB, Sponsor, and/or FDA as required by the protocol and the Federal Regulations. Follow AEs and SAEs until resolution.

8. Schedule interim monitoring visits and assist monitors in verifying trial data integrity. Perform query resolution in the various electronic data capture systems.

Laboratory

1. Complete all required training for working in a biological laboratory (e.g. Bloodborne Pathogens, Biomedical Waste Training, Chemical Hygiene Plan, Shipping and Transport of Biological Materials, etc.) and renew as needed to satisfy UF's Environmental Health & Safety requirements.

2. Prepare and ship central laboratory samples as per protocol requirements.

3. Keep lab clean and help Lab Manager prepare for annual lab inspections as needed.

Maintains working knowledge of computing skills: Microsoft Word for Windows, PowerPoint, Access, and Excel. Facilitates efforts for ongoing database(s) within the Division.

Expected Salary:

Salary is competitive and commensurate with education and experience.

Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

  • Clinical Research Coordinator III

    4 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coord III Job Description: The Clinical Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Sponsor Contract ( Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Manager, Healthcare

  • Clinical Research Coordinator III

    4 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coord III Job Description: The Clinical Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Sponsor Contract (Terms & Conditions), Conduct of Research, Clinical Services; Research Associate and other Staff Management,...

  • Clinical Research Coord III

    4 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator III Job Description: The Department of Health Outcomes and Biomedical Informatics is seeking an enthusiastic and qualified individual to fill the Clinical Research Coordinator III position. Join a highly productive team in helping prevent cancer and reduce the disparities due to hypertension within...

  • Research Coordinator III

    3 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Research Coordinator III Job Description: The Research Coordinator III (RC III) is responsible to the Director of Health. Street (Dr. Linda B. Cottler) and Deputy Director (Dr. Catherine Striley) and is the supervisor of all Hea Research Coordinator, Research, Operations Manager, Coordinator, Director, Health, Technology

  • Research Coordinator III

    4 days ago

    Gainesville, United States University of Florida Full time

    Classification Title: Research Coordinator III Job Description: Outreach Interact with stakeholder groups of the IR-4 Project including growers, commodity associations/grower groups, Cooperative Extension Agents & Specialists, Agricultural Experiment Station researchers, and others connected with pest management in specialty/minor uses. Also, interact...

  • Clinical Research Coord III

    4 days ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator III - GI Surgery Job Description: Administrative: Institutional Review Board: Must be knowledgeable in institution IRB and Western IRB policies, procedures, and standards of conduct. Create, coordinate, and/or develop research protocols, informed consent, and introductory questionnaires for IRB...

  • Clinical Research Coordinator I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: The Department of Pediatrics at the University of Florida is seeking a qualified and enthusiastic individual to coordinate research for multiple projects related to Type 1 Diabete Clinical Research, Research Coordinator, Clinical, Research, Coordinator, Healthcare, Education

  • OPS Clinical Research Coordinator

    4 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: OPS Sponsored Project Non-Clerical Job Description: The Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Conduct of Research, Clinical Research, Research Coordinator, Clinical, Coordinator, Research, Manager, Healthcare, Education

  • Clinical Research Coordinator I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: The Department of Pediatrics at the University of Florida is seeking a qualified and enthusiastic individual to coordinate research for multiple projects related to Type 1 Diabetes. This individual will work in a team setting and under the supervision of the Principal Investigators....

  • Clinical Research Coordinator I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I - Cardiovascular Surgery Job Description: Clinical Research Coordinator I coordinates ongoing clinical research trials within the Division of Cardiovascular Surgery under the direction of the seni Clinical Research, Research Coordinator, Cardiovascular, Clinical, Surgery, Coordinator, Healthcare

  • Clinical Research Coordinator I- Department of Neurosurgery

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: Coordination and Processing of Human Biological Samples This includes, but is not limited to the following tasks: Coordinate human biological sample collections from stroke patien Clinical Research, Research Coordinator, Clinical, Neuro, Research, Coordinator, Healthcare, Education

  • OPS Clinical Research Coordinator

    4 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: OPS Sponsored Project Non-Clerical Job Description: The Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Conduct of Research, Reporting, and Project Closeout procedures. Preparation and/or Review of Scientific Proposal * Assists...

  • Clinical Research Coordinator I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I - Cardiovascular Surgery Job Description: Clinical Research Coordinator I coordinates ongoing clinical research trials within the Division of Cardiovascular Surgery under the direction of the senior study coordinator. As part of an interdisciplinary health team, the incumbent will collaborate with...

  • Clinical Research Coord I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: The Department of Medicine, Division of Nephrology is seeking a full time Clinical Research Coordinator I. This position will participate in all aspects related to coordination of Clinical Research, Clinical, Research Coordinator, Research, Healthcare, Education, Regulatory, Compliance

  • Clinical Research Coord I

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: The Department of Medicine, Division of Cardiology is seeking a full time Clinical Research Coordinator I. This position supports our clinical trials and works under the direction Clinical Research, Clinical, Research Coordinator, Research, Healthcare, Education

  • Clinical Research Coord II

    1 week ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator II Job Description: The Department of Medicine, Division of Infectious Diseases and Global Medicine is seeking a full time Clinical Research Coordinator II. The position will involve execution of al Clinical Research, Clinical, Research Coordinator, Research, Healthcare, Education

  • Research Coordinator I

    3 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Research Coordinator I Job Description: Participant Recruitment and Data Collection: Position is responsible for a large portion of participant recruitment and study design, from physician referrals at the Springhill clinic, fli Research Coordinator, Research, Coordinator, Data Entry, Technology, Education, Database, Management

  • Clinical Research Coord I

    3 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coordinator I Job Description: Participate in the informed consent process of study subjects Assist patients in completing study related surveys and scratch and sniff olfaction testing Retrieve and process hu Clinical Research, Clinical, Research, Processing, Research Coordinator, Healthcare, Education

  • Clinical Research Coord II

    3 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Clinical Research Coord II Job Description: This position serves as the Clinical Research Coordinator II for the Perioperative Cognitive Anesthesia Network (PeCAN) Alzheimer's Disease and Related Disorders Program and other assigned studies. Responsible for day-to-day management of research projects, assisting with grant...

  • Research Coordinator I

    3 weeks ago

    Gainesville, United States University of Florida Full time

    Classification Title: Research Coordinator I Job Description: Participant Recruitment and Data Collection: Position is responsible for a large portion of participant recruitment and study design, from physician referrals at the Springhill clinic, fliers, direct mailers, The Brain Health Registry, and word of mouth. This position will complete consenting...