Clinical Research Nurse Phase 1

1 month ago

Miami, United States Nicklaus Children's Hospital Full time
Description

Job Summary

The Phase 1 Clinical Research Nurse Coordinator is part of a central team of specialized research professionals within the Nicklaus Children's Hospital Research Institute (NCH-RI). This research position reports directly to the NCH-RI Clinical Trials Office (CTO) Manager but works closely with Lead CRA's, Study Team (PI, Sub-I's, CRC', etc.), NCH-RI departments and Nicklaus Children's Hospital (NCH) department administrators, and other clinical research professionals to help ensure that clinical research and related activities are performed in accordance with all applicable Federal regulations, NCH/NCH-RI applicable policies and sponsor policies/requirements. This research position will also coordinate team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations.

Job Specific Duties
  • Coordinates team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) applicable guidelines and regulations, and within budget.
  • Plans logistical activity for procedures as per protocol and ensures thorough resource planning. Identifies risks on study and ensures that actions are implemented to mitigate risks identified.
  • Ensures study specific training materials, documents, and records are prepared and delivered or coordinate training, dry runs, simulations and tests as required.
  • Implements, monitors, and assesses the need for training programs to maintain staff skill proficiency, including annual validation and currency of required certifications and licenses.
  • Provides protocol-specific training to research study team and NCH hospital/department staff directly involved with the care/treatment of research patients.
  • Works with NCH-RI staff to assist with developing, updating and implementing new Research Standard Operating Procedures, guidance documents, standard work and work flows (related to early phase research).
  • Coordinates, plans, implements, and evaluates nursing care to clinical trial study participants including but not limited to Adverse Event reporting and other support activities.
  • Provides nursing-related care to clinical trial study participants as outlined (and applicable) in the study protocol.
  • Coordinates and executes the collection, compilation, and analysis of clinical research data from studies conducted by PIs and study teams at Nicklaus Children s and the NCH-RI.
  • Interacts with patients and families to recruit study subjects and ensures compliance with protocol guidelines and requirements of regulatory agencies.
  • Attends and participates in investigator meetings, pre-study visits/initiation or coordinator meetings. Produces quality documentation, including completion of assessments within the specified time.
  • Coordinates and responsible for the collection of blood samples (PK samples and other), cultures, tissues and other specimens as required by protocol.
  • Prepares oral presentations/written reports/data requests describing progress, trends and appropriate recommendations or conclusions as it relates to research at Nicklaus.
  • Communicates with the Sponsor or representatives regarding scheduling and facilitation of study monitor visits and facilitates communication between PI and Sponsor or Sponsor s Representatives.
  • Reviews protocol and provides study feasibility input to the NCH-RI Leadership and Study Start-up Team. Works with QI/QA team to ensure quality standards are being met and reports adverse events, protocol deviations.
  • Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
  • Assists with the design and implementation of protocols, forms/questionnaires and the preparation of amendments to protocols and/or modifications to study design as appropriate for local, Investigator Initiated studies.
Qualifications

Minimum Job Requirements
  • BSN - Bachelors of Science in Nursing
  • RN Licensure within the State of Florida or Multi-State Enhanced Nursing License Compact (eNLC) - maintain active and in good standing throughout employment
  • IATA certification completion required within 3 months of hire date
  • American Heart Association ACLS (Advanced Cardiovascular Life Support) certification required within 3 months of hire
  • American Heart Association PALS (Pediatric Advanced Life Support) certification completion required within 6 months of hire
  • American Heart Association BLS - maintain active and in good standing throughout employment
  • 2-4 years of professional research or healthcare experience
  • 1-3 years of Phase 1 clinical research experience
Knowledge, Skills, and Abilities
  • ARNP highly preferred
  • Clinical research certification (e.g., CCRC, CCRP, CRA) preferred
  • Bilingual in English/Spanish preferred
  • Pediatric Nursing experience in an acute care setting preferred
  • Experience in neurology, neurosurgery, or oncology preferred
  • Experienced with database management tools and/or REDCap preferred
  • In-depth knowledge of Phase I clinical trials
  • Demonstrated knowledge of clinical research trial design and execution
  • Experienced with electronic medical record and clinical trial management software applications
  • Strong written and verbal communication skills
  • Excellent interpersonal skills
  • Excellent problem-solving skills
  • Effective organizational and project management skills
  • Ability to pay close attention to detail
  • Ability to comprehend professional and scientific journals
  • Ability to apply principles of logical and scientific thinking to a wide variety of intellectual and practical problems
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Proficiency in Microsoft Office including Access, Word, Excel, Outlook, and PowerPoint
  • Willing to work off-hours depending on the study requirements


Job :

Research

Primary Location :

Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus

Department :

RI - ADMINISTRATION-50

Job Status

:Full Time

  • Clinical Research Nurse Phase 1

    4 weeks ago

    Miami, Florida, United States Nicklaus Children's Hospital Full time

    DescriptionJob SummaryThe Phase 1 Clinical Research Nurse Coordinator is part of a central team of specialized research professionals within the Nicklaus Children's Hospital Research Institute (NCH-RI). This research position reports directly to the NCH-RI Clinical Trials Office (CTO) Manager but works closely with Lead CRA's, Study Team (PI, Sub-I's, CRC',...

  • Clinical Research Nurse 1

    6 days ago

    Miami, United States The University of Miami Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami Health System, "UHealth", SCCC Department...

  • Clinical Research Nurse 1

    23 hours ago

    Miami, United States The University of Miami Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami Health System, "UHealth", SCCC Department...

  • Clinical Research Nurse 1

    2 months ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The SCCC department is seeking a Clinical Research Nurse that will...

  • Clinical Research Nurse 1

    7 days ago

    Miami, United States The University of Miami Full time

    Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The University of Miami Health System, "UHealth", SCCC Department...

  • Cns - Clinical Research Associate

    2 weeks ago

    Miami, United States C-Clinical at Miami Full time

    Job DescriptionJob DescriptionCNS - Clinical Research Associate (CRA)Our clinical research firm is expanding and we have an opportunity for a Senior CRA with CNS, oncology, or metabolic experience for our pharmaceutical company client. Site monitoring is a hybrid model of risk-based remote and on-site monitoring. We are looking for CRAs with experience, who...

  • Clinical Research Coordinator 1

    4 weeks ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami/UHealth Department of SCCC has an exciting...

  • Clinical Research Nurse 1

    6 days ago

    Miami, United States The University of Miami Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami/UHealth Department of SCCC has an exciting...

  • Clinical Research Nurse 1

    7 days ago

    Miami, United States The University of Miami Full time

    Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The University of Miami/UHealth Department of SCCC has an...

  • Clinical Research Coordinator 1

    1 month ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami/UHealth Department of SCCC has an exciting...

  • Clinical Research Coordinator 1

    1 month ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Neurology has an exciting opportunity for a Full...

  • Clinical Research Coordinator 1

    1 month ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Pediatrics has an exciting opportunity for a Full...

  • Clinical Research Coordinator 1

    4 weeks ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The SCCC department is seeking a Clinical Research Coordinator 1...

  • Clinical Research Coordinator 1

    3 weeks ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The department of Psychiatry has an exciting opportunity for a...

  • Clinical Research Nurse 1

    13 hours ago

    Miami, United States The University of Miami Full time

    Job SummaryThe University of Miami is seeking a highly skilled Clinical Research Nurse 1 to join our team. As a key member of our healthcare team, you will be responsible for delivering patient-centered care in a culturally competent manner, utilizing evidence-based standards of quality, safety, and service.Key ResponsibilitiesDeliver patient-centered care...

  • Clinical Research Coordinator

    3 months ago

    Miami, United States COLUMBUS CLINICAL SERVICES LLC Full time

    Job DescriptionJob DescriptionColumbus Clinical Services is looking for experienced Clinical Research Coordinators (CRC) for their fast-paced, high-energy, clinical research site.Availability morning, evenings and weekends. CRCs may work up to 40 hours a weekProficient with phlebotomy and infusions.Create source documents for protocols using eCRF...

  • Clinical Research Specialist

    1 week ago

    Miami, Florida, United States COLUMBUS CLINICAL SERVICES LLC Full time

    Position OverviewCOLUMBUS CLINICAL SERVICES LLC is seeking skilled Clinical Research Specialists to join our dynamic and fast-paced clinical research facility.Key Responsibilities:Availability for morning, evening, and weekend shifts, with the potential to work up to 40 hours per week.Expertise in phlebotomy and infusion procedures.Develop source...

  • Clinical Research Operations Coordinator

    1 week ago

    Miami, Florida, United States Clinical Trials Investment Group Full time

    Job OverviewThe Clinical Trials Investment Group is actively seeking a dedicated Clinical Research Operations Coordinator with a strong background in clinical research. Bilingual candidates are preferred.Key Responsibilities:Oversee and coordinate clinical research activities effectively.Provide essential support to investigators in preparing and executing...

  • Registered Nurse 1- Doral A Clinic

    3 weeks ago

    Miami, United States UHealth Tower Full time

    Registered Nurse 1- Doral Clinic Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet. The University of Miami Health...

  • Clinical Research Nurse 2

    3 weeks ago

    Miami, Florida, United States UOMUOMUS Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.The University of Miami/UHealth Department of SCCC has an exciting...