CLINICAL TRIAL RESEARCH NURSE
4 weeks ago
The Alliance for Clinical Trials in Oncology Foundation is looking for a Clinical Trial Research Nurse who is excited to provide clinical expertise and oversight to clinical trials from the initial study design through the final study close-out. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.
Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:
• 8 weeks of paid time off (including PTO, sick, and holidays) during year one
• Medical, Dental & Vision plans with 100% employer-paid option for employees
• Tuition reimbursement stipends
• Continuing Education
• 3% employer match for retirement investments
• Annual Employee Performance Bonus Program
• Annual Cost of Living Adjustment
• 50% commuter reimbursement
• Healthy Work/Life balance and flexibility
ROLE & RESPONSIBILITIES
The CTRN is an essential member of the Quality Management Team and is responsible for ensuring protocol compliance by conducting centralized clinical monitoring and safety/pharmacovigilance activities.
- Assists with the design, planning, implementation, conduct and management of Alliance clinical trials from initiation through completion
- Develops study-related documents together with the scientific team and protocol development team including, but not limited to study protocols, informed consent forms, study plans, etc.
- Ensures protocol compliance in conjunction with the study team and collaborators through the provision and documentation of training
- Identifies and evaluates safety risks, recommends the need to correct identified deficiencies, and provides recommendations for protocol modifications to remove the source of the risk
- Triages clinical questions from sites, determining the necessity for escalation to other study team members
- Works with the protocol team and site engagement staff to identify and implement efficiencies and processes for site engagement
- Helps build and maintain relationships with sites and site study staff
- Serves as backup for reviews of SAEs safety listings generated by Pharmacovigilance (PV) units and/or data, before submission to regulatory authorities (e.g., DSUR, IND Safety Updates) for potential trends affecting overall trial safety
- Serves as back up response to sites' inquiries received in the pharmacovigilance mailbox
- Serves as backup reviews expedited adverse event reports, including SAEs/AESls for Alliance NCTN trials, in addition to associated external cross-reports
- Other related duties as assigned to meet departmental and company objectives
Requirements
Qualifications and Education Requirements
- Must have an RN/OCN, BSN, or other advanced nursing degree
- Maintains nursing professional competence necessary to perform job responsibilities; maintains licensure; maintains and provides agency with records of continuing education activities
- 3 years or more of clinical trial research nursing experience (oncology preferred) with working knowledge of Serious Adverse Event (SAE) reporting (documenting and reporting of events)
- Knowledge and experience with electronic medical records (EHR)
- Knowledge of the clinical trial process and related regulations including the Food & Drug Administration (FDA) and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP)
- Ability to manage multiple projects effectively
- Ability to work effectively in teams, as well as independently
- Ability to organize medical and scientific information to provide comprehensive support to Medical monitors and study team members
- Ability to manage confidential health information and data
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