Responsibilities/ Job Duties:
Clinical Research Nurse (CRN) Responsibilities, as delegated by the Principal Investigator (if required):
a) Standard Clinical Research Coordinator tasksb) Phlebotomy (peripheral veins only)c) Non-invasive sample collection (mouth swab, urine, sputum, etc.)d) Perform ECG (excluding analysis)e) Collect and record of basic vital signsf) Administration of investigational product limited to the followingIntermuscular, subcutaneous, or intradermal injectionNasal administrationDispensation of oral productsPosition Summary
- Develop, coordinate, and implement research and administrative strategies essential to the management of clinical trials research
Essential Functions
- Coordinate multi-site or large-scale clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet objectives of assigned research protocol(s).
- Assesses patients for protocol eligibility and communicates findings to investigator/physician.
- Coordinates the implementation of protocol procedures.
- Operates specialized equipment as needed in assigned area, if applicable.
- Assesses and monitors patient responses and adverse reactions; reports same to accountable sources.
- Provides appropriate patient and family education.
- Completes a variety of reports, documents, and correspondence for regulatory agencies, participating clinical trial sites and for internal purposes.
- Collaborates with physicians and other healthcare staff to ensure adherence to FDA and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
- Assist in the preparation and submission of amendments to clinical trials protocols to the IRB.
- Provides educational in-services as needed.
- Promotes interdepartmental cooperation and coordination for each protocol.
- Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state, and local standards.
- Maintains compliance with all Orlando Health policies and procedures.
Other Related Functions
- Assists in the development of treatment orders for active studies, to be reviewed by the treating physician.
- Assists the research team in preparing for site audits.
- Attends appropriate departmental and/or corporate meetings
- Attends study group and investigator meetings as required.
- Demonstrates ability in using computer software specific to department.
Minimum Education and Experience Qualification Requirements:
- Minimum of (3) year clinical research experience.
- Bachelor's degree in health-related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management); or
- Associate degree in related field (i.e., Healthcare Administration, Nursing, Respiratory Therapy, Health & Wellness or Health Information Management) and one (1) year of clinical research or healthcare experience (in addition to the requirements listed in the Experience section); or
- Graduate of an accredited allied health program and one (1) year of clinical research or healthcare experience (in addition to the requirements listed in the Experience section).
- If no degree, experience may be substituted at a two for one ratio and a minimum of two years clinical research experience required.
Licensure/Certification
- All RNs and other Clinical Research Coordinators involved in direct patient care may be required to be licensed by the medical director.
- Must be eligible for Certified Research Coordinator CCRC/CCRP by the Association of Research Professionals or SOCRA (Society of Clinical Research Associates within one year of hire.
- BLS/Healthcare Provider certification required.
Schedule/ Shift: 40 hours a week, M-F
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