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Job Requirements of Clin Research Nurse II AES:
-
Employment Type:
Contractor
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Location:
Ocala, FL (Onsite)
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Clin Research Nurse II AES
Careers Integrated Resources Inc
Ocala, FL (Onsite)
Contractor
Job Title: Clin Research Nurse II AES
Job Location: Ocala FL
Duration: 6 Months+
Job Description: Summarized Purpose:
Essential Functions:
Job Location: Ocala FL
Duration: 6 Months+
Job Description: Summarized Purpose:
- Acts as a Lead Coordinator in a site setting whereby they may be leading logistics, vendor/stakeholder management, answer complex protocol and Alzheimer's questions.
- Oversee multiple ongoing clinical trials involving patients. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process.
- Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants.
Essential Functions:
- Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provides medical care to patients, always ensuring patient safety comes first.
- Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
- Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
- Records all patient information and results from tests as per protocol on required forms.
- Where required, may complete IP accountability logs and associated information.
- Reports suspected non-compliance to relevant site staff.
- Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
- Promotes the company and builds a positive relationship with patients to ensure retention.
- Attends site initiation meetings and all other relevant meetings to receive training on protocol.
- May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
- Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
- Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
- Adheres to company COP/SCOP.
- May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
- Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
- Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.).
- Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving.
- Demonstrated ability to exercise discretion and sound judgement
- Good decision-making, negotiation and influencing skills
- Good communication skills and English fluency will be an advantage
- Good organizational skills.
- Good proficiency in basic computer applications.
- Good interpersonal skills to work in a team environment
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