Title: Research Nurse Administrator
Location: Upper East Side
Org Unit: Maternal Fetal Medicine
Work Days:
Weekly Hours: 35.00
Exemption Status: Exempt
Salary Range: $161,200.00 - $187,500.00
*As required under NYC Human Rights Law Int [redacted] - Salary range for this role when Hired for NYC Offices
Position SummaryUnder general guidance, reports to the Associate Director of the CCTO and the Medical Director of the CCTO. The Research Nurse Administrator oversees the Research Nurse Unit in the Cancer Clinical Trials Office and is responsible for the day-to-day management of the Research Nurse Specialist and Medical Assistant across the Meyer Cancer Center (MCC).
Job Responsibilities- Serves as a central point person for nursing related matters and issues. Provides guidance on clinically related questions within research programs. Troubleshoots potential issues and facilitates smooth clinical study operations.
- Recruit, train, and supervise Research Nurse Specialists and Medical Assistants to ensure compliance and efficiency.
- Reviews and implements necessary nursing competencies. Ensures that nursing staff's licensure and certifications are current as required by regulatory agencies.
- Ensures that all clinical staff maintain good quality source documentation according to ICH-GCP guidelines and FDA regulations and HIPAA requirements.
- In collaboration with the Associate Director, conducts workload assessments, implements, and evaluates optimization strategies to ensure adequate staffing for research programs.
- Identifies, communicates, and aids in SOP development and establishment of guidelines and processes in an effort to improve efficiency and overall conduct of research programs.
- Participate in institutional committees as MCC CCTO representative. Serve as clinical trial operations expert in clinical research policies and workflow, providing feedback on clinical research operations and staffing capabilities.
- Participate in process improvement projects and provide clinical trial operations perspective and impact.
- Collaborate with the Epic/Beacon build team members to ensure that study treatment plans are built in according to the protocol for newly activated and amended therapeutic protocols, as needed.
- Provides direct patient care as needed to meet clinical research needs and precepts and mentors research personnel in related tasks.
- Responsible for various aspects of study treatment protocols, as deemed necessary; educates participants; reports adverse events; monitors participants on studies.
- Contributes to the implementation of research protocols and the clinical management of patients on protocol in compliance with federal regulations, GCP guidelines, and internal policies.
- Ensures compliance with regulatory audits/inspections and/or interval reviews. Develops and recommends corrective action plan to address deficiencies identified.
- Performs other related duties as assigned.
Education- Bachelor's of Science Degree in Nursing
Experience6+ years of related clinical research nurse experience.
Oncology clinical research experience preferred.
Supervisory and management experience preferred.
Knowledge, Skills and Abilities- Strong knowledge in Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
- Excellent oral and written communication skills
- Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations (sponsors and contract research organizations).
- Proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel) and database applications.
- Demonstrated organizational skills and ability to pay close attention to detail.
- Demonstrated critical thinking and analytical skills.
- Demonstrated ability to multi-task and prioritize in a fast-paced environment.
- Demonstrated ability to remain focus despite frequent interruptions.
- Ability to treat confidential information with utmost discretion.
- Demonstrated ability to exercise standards of professionalism, including appearance, presentation, and demeanor.
- Demonstrated ability to work effectively in a collaborative manner with departmental faculty and staff, as well as other institutional representatives.
- Ability to work both independently and as part of a team.
Licenses and Certifications- Current NY State Registered Nurse License & Registration.
- BLS certification, issued by the American Heart Association.
- Infection Control Certificate
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.
Working Conditions/Physical DemandsStandard office work
