The Clinical Research Nurse Coordinator Ph1 (CRNC1) is part of a central team of specialized research professionals within the Miami Children's Research Institute (MCRI) and Nicklaus Children's Hospital. CRNC1s report directly to the Supervisor of the MCRI Clinical Trials Unit but works closely with PIs, MCRI and Nicklaus Children's administrators, and other clinical research professionals to help ensure that clinical research and related activities are performed in accordance with all applicable Federal regulations and MCRI and sponsor policies and procedures. The CRNC1 will coordinate team activities to ensure studies are carried out according to protocol, standard operating procedures (SOPs) and applicable guidelines and regulations.
Essential Job 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 training to new staff members on study-specific topics and new clinical skills. Assists in ensuring compliance with staff training requirements by auditing and maintaining training records.
Develops, updates and implements MCHS Standard Operating Procedures and work flows.
Coordinates, plans, implements, and evaluates nursing care to clinical trial study participants including but not limited to Adverse Event reporting and other support activities.
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 MCRI.
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 the collection and shipments of blood samples, cultures, tissues and other specimens as required by protocol.
Prepares oral presentations/written reports describing progress, trends and appropriate recommendations or conclusions. Presents findings at conferences and other professional speaking engagements.
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 MCRI Administrative Team. Works with QA to ensure quality standards are being met and reports adverse events, protocol deviations.
Coordinates and performs study specific regulatory processes in accordance to appropriate federal regulations, ICH GCP guidelines, organization policies and procedures, & study specific protocols.
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.
ARNP highly preferred
Bilingual in English/Spanish preferred
Pediatric Nursing in an acute care setting preferred
Experience in neurology, neurosurgery, or oncology preferred
Experienced with database management tools and/or REDCap preferred
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 and willing to travel to offsite locations
Minimum Job Requirements:
RN licensure within the State of Florida
BSN – Bachelors of Science in Nursing
5 years of professional research or healthcare experience
2 years of phase 1 clinical research experience
In-depth knowledge of Phase I clinical trials
IATA certification completion within 3 months of hire
Clinical research certification (e.g., CCRC, CCRP, CRA) completion within 1 year of hire required
CPI (Crisis Intervention Training) required within 90 days of hire
CPR: Healthcare Provider
ACLS (Advanced Cardiovascular Life Support) certification
PALS (Pediatric Advanced Life Support) certification completion within 2 years of hire