Job Details
The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.
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