Job Description

Join to apply for the RN, Clinical Research role at CARTI .

Brief Description

The RN, Clinical Research executes and coordinates daily clinical research activities according to GCP and FDA/ICH guidelines; reviews and assists in the selection of sponsor-supported clinical trials; completes and organizes all IRB/Sponsor regulatory documents; negotiates clinical trial budgets and invoices for site activities; ensures IRB-approved protocols are implemented and followed; educates patients and their families about clinical trial treatments and possible side effects; executes and documents the informed consent process and monitors patient status and safety; collects, organizes and reports research data; schedules and conducts study-specific training and site in-services to study-related staff on new or amended protocols; conducts visits with CRAs (Clinical Research Associates) to initiate protocols and to verify source documents; maintains investigational product inventory and oversees the dispensing of investigational product to patients; reports regularly to the Principal Investigator on the status of all open clinical trials under his/her supervision. Works closely with the laboratory to ensure samples are collected and processed according to protocol.

Responsibilities

• Enlist, maintain, and assure protocol compliance for all patients on clinical trials.
• Collaborate with physicians to determine eligibility of patients for clinical trials.
• Practice in compliance with SOPs, GCP, and applicable federal, state, and local regulations.
• Screen potential patients for protocol eligibility; present trial concepts and details to the patients; participate in the informed consent process; enroll patients on protocol.
• Coordinate patient care in compliance with protocol requirements; may disburse investigational drug and provide patient teaching regarding administration; maintain investigational drug accountability.
• Review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document all findings.
• Accurate and timely data collection, documentation, entry, and reporting; schedule and participate in monitoring and auditing activities.
• Maintain regulatory documents in accordance with SOPs and applicable regulations.
• Participate in required training and education programs; educate clinic staff regarding clinical research.
• Additional responsibilities may include working directly with other research bases and/or sponsors.
• Provide a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
• Interact with the Clinical Trial Sponsors to recruit new clinical trials for the site; conduct feasibility questionnaires and participate in site selection process.
• Negotiate the clinical trial budget with the Sponsor and invoice for the completed site activities.
• Order and maintain inventory of all study-specific supplies including recruitment materials and specific lab kits.
• Collect, process and ship all study-defined lab kits to the Central Lab as directed by the sponsor.

Qualifications

• Graduate from an accredited school of nursing.
• Associates degree or equivalent from a two-year college program, technical school, or nursing diploma.
• Bachelors degree, preferred.
• Current registered nurse licensure in Arkansas.
• BLS certification.

Experience, Knowledge, Skills & Abilities

• Two or more years of experience in clinical research or oncology, preferred.
• Proficiency with Microsoft Office applications (Outlook, Word, Excel).
• Detail oriented, organized, self?motivated, able to work independently and on a team.
• Excellent communication, teamwork and problem?solving skills.
• Professional, high work ethic, strong work ethic, ability to adapt to additional tasks.
• High integrity and ability to maintain confidentiality.

Other Requirements

• Occasional travel to satellite clinics.

Seniority Level

• Entry level

Employment Type

• Full?time

Job Function

• Health Care Provider
• Hospitals and Health Care industry

Job Tags

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