141325
Job Description
Facilitates complex and/or large-scale research projects involving direct patient care. Leads and guides project staff members in the performance of duties. Ensures adherence to established protocols to ensure projects are carried out as directed by the Institutional Review Board (IRB). Works within scope of practice to perform clinical procedures. Collaborates with physicians and clinical/ancillary team members to ensure integrity of research study.
Job Responsibility
- Participates in complex and/or large-scale research project planning to determine feasibility of protocol implementation based on demonstrated knowledge of institutional capabilities/limitations, therapy, and/or population of interest; makes recommendations for study enhancement, as appropriate.
- Collaborates with internal stakeholders to determine patient eligibility for clinical trial, including documentation of criteria specified in the protocol; identifies and develops processes to overcome recruitment barriers.
- Ensures initial/ongoing consent process is performed and documented in compliance with the US Food and Drug Administration (FDA), Good Clinical Practice, institutional policies, sponsor requirements, Institutional Review Board (IRB) and related applicable regulations, guidelines and policies.
- Provides orientation and ongoing training to assigned project staff members on established protocols and procedures; serves as a resource for difficult or complex patient care issues.
- Educates research subjects, families and healthcare team members on research study specifics and significant new information arising during conduct of trial. Performs clinical procedures including, but not limited to, vital signs, phlebotomy, specimen collection, electrocardiograms, administration of investigational agent (under PI supervision), IV placement, catheters and patient assessment/questionnaire completion.
- Collaborates with internal stakeholders to assess patients for adverse events; documents and reports findings per protocol, FDA, sponsor, and IRB policies; promotes respect and advocates for the safety and care of clinical research subjects; discusses potential protocol changes with internal stakeholders, as required.
- Monitors study routine to ensure timely progress and compliance with regulatory and granting agencies, reports on findings, administers and scores assessments; evaluates disease response results and physical assessment data, in conjunction with PI, to determine response per protocol; reports findings to internal/external sponsors.
- Coordinates related audit preparation and facilitation, including FDA, IRB and related internal and external monitors and auditors; interfaces with the Office of Grants and Contracts (OGC) and IRB to ensure all documents are processed and maintained per applicable regulations.
- Collaborates with stakeholders to organize all phases of grant process for submission to funding agencies and to ensure adherence to clinical trial agreement/study budgets.
- Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
Job Qualification
- Bachelor of Science in Nursing required.
- Current License to practice as a Registered Professional Nurse in New York State required, plus specialized certifications as needed.
- 5-7 years of relevant experience and 0-2 years of leadership / management experience, required.
Preferred Skills/Experience
- Experience in Research Oncology
- Additional Salary Detail The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).
