Job Details
Description
Job Summary:
The Clinical Research Nurse (CRN) 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 CRA's (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 Principle Investigator on the status of all open clinical trials under his/her supervision. Works closely with the laboratory to ensure samples are collect and processed according to protocol.
JOB SPECIFIC DUTIES AND RESPONSIBILITIES:- Under direct supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
- Collaborates with physician in determining eligibility of patients for clinical trials.
- Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
- Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
- In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
- Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities.
- Maintains regulatory documents in accordance with SOPs and applicable regulations.
- Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
- Additional responsibilities may include working directly with other research bases and/or sponsors.
- Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
- Interacts with the Clinical Trial Sponsors to recruit new clinical trials for the site. In collaboration with the Principle Investigator, conducts feasibility questionnaires and participates in site selection process.
- Negotiates the clinical trial budget with the Sponsor and invoices 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.
OTHER JOB REQUIREMENTS: Occasional travel to satellite clinics.
EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION:RN license in good standing
EXPERIENCE, KNOWLEDGE, SKILLS and ABILITIES: - Two or more years of experience in clinical research or oncology
- Must be proficient with Microsoft office applications (Outlook, Word and Excel)
- Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
- Must have excellent communication, teamwork and problem solving skills;
- Must be professional, possess a high degree of self-motivation and have a strong work ethic.
- Must have the ability to adapt and take-on additional tasks as requested;
- Must be capable of recognizing, and have the willingness, to resolve errors and issues;
- Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
REASONING ABILITY:- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, or schedule form.
INTERPERSONAL SKILLS:- Must interact and communicate both verbally and in written form.
- Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.
PHYSICAL DEMANDS:- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
- Specific vision abilities required by this job include close vision and the ability to adjust focus.
WORK ENVIRONMENT:The work environment described here are representative of those an employee encounters while performing the essential functions of this job. This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.
COMMENTS:This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of the job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
SAFETY SENSITIVEThis position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.