- Assists the principal investigator in the preparation of proposed clinical trials by reviewing trial protocol, contacting each department who will provide resources during study and ensuring appropriate departments are notified and given a copy of proposed trial, scientific merit and accrual potential
- Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner
- Acts as liaison between principal investigators and sub-investigators on all regulatory issues and changes within the protocol.
- Interacts with regulatory specialists and principal investigators and sub-investigators on all regulatory issues and changes within the protocol
- In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study
- Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
- Recruits and evaluates potential study patients, and works with clinical research coordinator to schedule required appointments and interviews
- Identifies the needs of the patient population served and modifies and delivers care that is specific to those needs (i.e., age, culture, hearing and/or visually impaired, etc.). This process includes communicating with the patient, parent, and/or primary caregiver(s) at their level (developmental/age, educational, literacy, etc.)
- Reviews medical records for potential study patients and ensures that medical records include documentation of all laboratory test results and procedures and progress of study patients, following guidelines set forth by the protocol sponsors
- Instructs potential study patients, designated caregiver, physicians, nurse clinicians and other ancillary staff members involved in the care of the patient on aspects of patient¿s care, available trials, treatments and side effects
- Assists investigator with consent process assuring study patients understand clinical trials and obtains written informed consent
- Educates study patients concerning informed consent procedures, HIPAA authorization
- Documents study patient¿s medical history including but not limited to past medical/surgical treatments, significant medical conditions, and medication history per protocol guidelines
- Performs nursing assessments and monitors study patient¿s progress during clinical trials; Tracks study patient¿s response by documenting on toxicity flow sheet, medication flow sheet and nurses¿ progress notes.
- Graduate of a NLN/AACN accredited program in nursing, BSN Preferred
- Current valid NJ State Professional Registered Nurse license required
- 3 years clinical nursing experience or 1 year of clinical nursing experience with an additional 2 years of clinical research experience
- Adheres to the American Nurses Association standards
- Strong attention to detail and customer service focus is required
- Excellent communication, organizational, presentation, documentation, and interpersonal skills are required
- Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email (Outlook), and voicemail is required
- Review and comply with all relevant HUMC and Business Unit policies and procedures, and local, state, and Federal laws and regulations
- Mandatory education on human subject research and GCP (CITI Training and Certification) preferred
- Knowledge of clinical trials and the regulation (local, state, and federal) of such preferred
- Familiarity with basic scientific and healthcare principles and terminology preferred
- Ability to work in a fast-paced environment and manage competing tasks and demands
- Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC)
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Research Nurse - Hackensack, United States - Hackensack Meridian Health
Description
Overview
Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees areteam members. Here, competitive benefits are just the beginning. It's also about how we support one another and how we show up for our community. Together, we keep getting better - advancing our mission to transform healthcare and serve as a leader of
positive change.
The Clinical Research Nurse is responsible for coordinating and overseeing clinical operations of a clinical trial and participates in assessing, planning, implementing and evaluating Compliant Patient Care in clinical research studies. The Clinical Research Nurse carries out the research and works under the general supervision of the principal investigator responsible for the clinical trials.
This research position is for Leukemia research, so we are looking for someone with oncology and/or research experience
Responsibilities
A day in the life of a Clinical Research Nurse at Hackensack Meridian Health may include the following:
Qualifications
