Clinical Research Nurse - Phase 1 (Full Time, Day shift)
Nicklaus Children’s Health System
Location: Miami, Florida
Internal Number: 25499
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.
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 - maintain active and in good standing throughout employment
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
4-7 years of professional research or healthcare experience
2-4 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
Primary Location :
Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus
Nicklaus Children’s Health System, is the region’s only healthcare system exclusively for children. In addition to Nicklaus Children’s Hospital and a growing number of outpatient centers located throughout the tri-county area, the health system includes Nicklaus Children’s Hospital Foundation, the organization’s fundraising arm; Nicklaus Children's Pediatric Specialists, a nonprofit physician practice subsidiary; a management services organization, and an ambulatory surgery center. Our vision is to be where the children are. Ultimately, this means being there through all stages of health and life, both physically and emotionally. To be a trusted partner to children and their families, not only in times of illness, but throughout their life journey. Our mission is to inspire hope and promote lifelong health by providing the best care to every child.