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Clinical Research Nurse Phase 1 - Onsite (Full Time, Day shift)

Company: Nicklaus Children's Hospital
Location: Miami
Posted on: June 7, 2024

Job Description:

DescriptionJob 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-2100-380950

Job Status
:Full Time

Keywords: Nicklaus Children's Hospital, Miami , Clinical Research Nurse Phase 1 - Onsite (Full Time, Day shift), Healthcare , Miami, Florida

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