Clinical Research Nurse - 237352 New

Role: Clinical Research Nurse

Duties include but are not limited to:

• Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement”
• During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
• Complete study medication order forms accurately, when needed, and has physician or appropriate designee sign orders prior to medication administration
• Perform routine operational activities for multiple research protocols
• Liaise between site research personnel, industry sponsors, and Supervisor
• Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
• Coordinate protocol schedule of assessments from initial submission of feasibility until study closeout
• Coordinate submission and approval for the Site’s Facility Review Committee, if applicable
• Provide instruction on research protocols to appropriate staff, including interpretation of test results, observations, and related study data to physicians, nurses, and clinical staff
• Assess the patient and document findings at each clinic visit while on protocol
• Document all specific tasks required by the protocol (i.e. medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws, etc.)
• Complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment
• Ensure that all medications are approved by the appropriate designee prior to initiating treatment or when changing medication regimens
• Accurately calculate and document the BSA, creatinine, STS calculation, or any other conversions needed, per protocol
• Document any interaction regarding the patient that occurs while the patient is enrolled on a protocol, including follow-up and survival (this includes home health intervention, pharmacies, and patient phone calls)
• Ensure that follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements
• Accurately complete all data requests (including queries) and submit with source documentation within the timeframe specified in the SOP
• Generate and track drug shipments, device shipments, and supplies as needed
• Ensure timely and accurate data completion
• Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations
• Communicate all protocol-related issues to appropriate study personnel or manager
• Re-consent patients in a timely manner and document process appropriately

Minimum Education and Experience Qualification Requirements:

• Must have an active, unencumbered nurse license (RN or LVN) in FL 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 preferred
• 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