Role: Clinical Research Nurse
Therapeutic Area: Ophthalmology – Thyroid Eye Disease
Employment Type: 9 month contract, potential for extension
Schedule/ Shift:
Location: Newport Beach, CA 92660
- **Relocation candidates will NOT be considered at this time
Responsibilities/ Job Duties:
Requesting full time Clinical Research Nurse for the project below - 100% onsite. Employee will be splitting time between multiple protocols for a total of 40 hours a week, M-F during daytime hours.
Project Support Scope:
Clinical Responsibilities:
- Administering / preparing investigational product
- Subcutaneous injections
- EKGs
- Phlebotomy
- Collecting vitals
Recruitment:
- Chart review – onsite
- Pre-screening for eligibility to protocol
Retention:
- Data entry and data migration
- Query Resolution
- AE monitoring
- Scheduling and appointment reminders
Administrative Tasks:
- Study visit and audit preparation – monitoring visits
- Consenting
- Administrative tasks – maintaining study binder, regulatory filing, etc.
- Source Document Creation
- Regulatory document maintenance, preparation, and submission of study level IRB/Regulatory documents from approved templates
Minimum Education and Experience Qualification Requirements:
- Must have an active, unencumbered nurse license (RN or LVN) in California to be considered for this role.
- Nurses must have experience with administering / preparing IP, administering subcutaneous injections, EKGs, and phlebotomy
- Minimum 2 years clinical trial coordination experience required
- Experience with EDC data entry/management, query resolution required
- Experience with study visit management including screening, enrollment, consenting, etc. required
- Experience managing regulatory documentation including managing regulatory binders required
- Ophthalmology experience preferred
Benefits:
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)
- Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)
- 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1)
- Short Term Disability Insurance
- Term Life Insurance Plan
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.