Clin Research Nurse Coor III

  •  

Philadelphia, PA

Industry: Healthcare

  •  

5 - 7 years

Posted 112 days ago

Job Summary

Duties: Provides daily overall clinical management of a Phase 3, multi-site, international research study of critically ill pediatric patients supported on mechanical ventilation in Pediatric Intensive Care Units (PICUs) . Develops multi-disciplinary training and educational materials; coordinates training video production and online training tools. Conducts training and certification of clinical staff at 45 international PICU study sites. Provides oversight of administration of study intervention per protocol. Liaisons with data coordinating center to provide clinical review and quality management on all clinical data and adverse events. Performs site monitoring and organization of staff performance at PICU sites to promote patient safety within the scope of the study. Plans multidisciplinary clinical meetings and liaisons with all sites to evaluate protocol compliance and staffing. Prepares regulatory and technical progress reports and drafts articles for publication. Works in collaboration with the Principal Investigator and the research teams with project start-up, daily operations and project activities, monitoring and study closure as required. Position is contingent on continued funding.

 

Qualifications: MSN with a minimum of 3-5 years' experience in pediatric critical care research or Advanced Practice Nurse in Critical Care. Current licensure as a Registered Nurse. Clinical expertise with advanced knowledge of the critical care environment, sedation and mechanical ventilation required. Prior research experience managing clinical trials or study monitoring experience preferred. Knowledge of pediatric regulatory compliance issues preferred.

Solid presentation and training skills needed, including web and video development of educational materials and documents.

Excellent interpersonal skills with the ability to interface with all staffing levels in a fast-paced environment using sound judgment and practical understanding. The successful candidate will possess a high level of initiative, accountability and professionalism. Must be a collaborative team player with the ability to work both independently and as part of a research team in partnership with PI and clinical coordinating center. Excellent writing skills essential. Strong analytical and organizational skills with the ability to multi-task and meet deadlines essential. Strong PC related skills in MS Office and web-based meeting platforms. Prior supervisory experience needed. Some domestic travel to train at collaborating sites. On-call availability.

Job Responsibilities

 

•             Develops consent forms for approval by Human Subjects Panel.

•             Coordinates new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. 

•             Completes annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies.  Submit Investigational New Drug applications to the FDA as required

•             Monitors Institutional Review Board submissions, and responds to requests and questions.

•             Oversees financial resources, as needed, creates internal and external budgets for research protocols, assures financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.

•             Work collaboratively and effectively with the individual study management teams, various core groups at CHOP's Research Institute and other participating institutions.

•             Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed.

•             Oversee clinical trial budget preparations and billing plans and resolution of billing/budget issues.

•             Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.   

Required Licenses, Certifications, Registrations

RN - Registered Nurse

CPR - Certified Pulmonary Recuscitation

Required Education and Experience

Required Education: BSN

Required Experience: 5+ years research

Preferred Education, Experience & Cert/Lic

MSN with a minimum of 3-5 years' experience in pediatric critical care research or Advanced Practice Nurse in Critical Care. Current licensure as a Registered Nurse. Clinical expertise with advanced knowledge of the critical care environment, sedation and mechanical ventilation required. Prior research experience managing clinical trials or study monitoring experience preferred. Knowledge of pediatric regulatory compliance issues preferred.

Solid presentation and training skills needed, including web and video development of educational materials and documents.

Excellent interpersonal skills with the ability to interface with all staffing levels in a fast-paced environment using sound judgment and practical understanding. The successful candidate will possess a high level of initiative, accountability and professionalism. Must be a collaborative team player with the ability to work both independently and as part of a research team in partnership with PI and clinical coordinating center. Excellent writing skills essential. Strong analytical and organizational skills with the ability to multi-task and meet deadlines essential. Strong PC related skills in MS Office and web-based meeting platforms. Prior supervisory experience needed. Some domestic travel to train at collaborating sites. On-call availability.

 

Additional Technical Requirements

Clinical Research Nurse responsibilities include but are not limited to CHOP mandatories and competencies for nurses, physical assessment, vital signs, administering investigational drugs and accessing lines for labs and pharmacokinetic sampling.

20385

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