Clinical Research Nurse

Registered Nurse

The Registered Nurse will perform a variety of activities related to the clinical area, including medical support systems and assisting medical personnel with study participants care duties as assigned. Incumbents work under supervision of clinical staff, performing routine duties and primarily, referring questions and problems to the Clinical Research Coordinator assigned to study or the PI.

Responsibilities

Clinical:

• Perform study events and collects clinical data as per protocol requirements.
• Administer study drug as assigned.
• When assigned, serve as Pharmacy Staff.
• Discuss and administer Informed Consent Form, as assigned (dependent on site)
• Notify appropriate staff of abnormal results while collecting data, adverse events, or unusual incidents.
• Assure minimal discomfort for study participants while performing all duties.
• Working knowledge of telemetry monitoring and interpretation of tracings
• Maintain safety and well-being of study participants during assigned shift.
• Knowledge of Holter monitor skills.
• Prepare participants for events.
• Understand all functions of telemetry monitoring machine.
• Collect all telemetry tracings for licensed personnel to review.
• Ability to use proper advanced life support equipment and supplies.
• Maintain skills in the use of ECG machine, taking accurate vital signs and IV insertion.
• Keep apprised of all new OSHA, BLS, ACLS and GCP/ICH rules, regulations, and procedures.
• Perform initial evaluation of adverse event.
• Knowledge of drug reactions and the synergistic effects of drugs combined with other medicines.
• Ability to apply basic principles of mathematics to the calculation of problems associated with medication dosages.
• Must be capable of providing advanced life support emergency medical services, including conducting of and interpreting ECGs, electrical interventions to support cardiac functions, performing advanced endotracheal intubations in airway management and relief of pneumothorax and administering of appropriate intravenous fluids and drugs under direction of a designated physician.
• Stay focused while assuming the leadership role inherent in carrying out the functions of the position.
• Provide top quality care and concurrently handle high levels of stress.

Administrative:

• Read and understand each protocol in which he/she is involved.
• Maintain knowledge and understanding of SOP for data collection.
• Maintain accurate and neat documentation records as required by the protocol.
• Follow proper safety procedures and report to supervisor immediately all injuries, unsafe practices, and unusual incidents.
• Know OSHA and GCP/ICH rules and regulations and comply with all requirements.
• Perform inventory of supplies needed and report deficiencies to clinical staff supervisor.
• Stay on duty/assigned shift until relieved by oncoming staff.

Educational:

• Maintain current licensure, registration and/or certification within educational background.
• Maintain current BLS and/or ACLS certification
• Maintain necessary CEU's for licensure, registration and/or certification.
• Assist in training new Paramedics, Emergency Medical Technicians (EMT), Medical/ Nursing Assistants (MA, NA) and Phlebotomy Technician
• Actively participate in ongoing Quality Assurance Program, HIPAA, and Compliance Programs
• Keep apprised of all new OSHA and GCP/ICH Rules and Regulations
• Attend all appropriate team meetings regarding study protocols.
• Learn and maintain skills in use of EKG machines and taking accurate vital signs.
• Read and understand site policy and procedures manuals, SOP manual, and employee handbook.

Additional Responsibilities:

• Comply with all site policies and procedures, especially those regarding protocol confidentiality.
• Demonstrate a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of the clinic.
• Maintain an overall good work attitude, promoting cooperation and professionalism and interactions with other staff members.
• Maintain assigned work areas in a clean, safe condition, and report any potential hazards immediately.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.

Skills and Qualifications:

• Education and experience
  • Licensure as a Registered Nurse (RN) in the applicable state with ACLS Certification and a minimum of one year experience as an
  • RN in a medical facility
  • Clinical Research experience preferred but not required.
  • ACLS certification required.
• Requirements
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Knowledgeable in medical terminology
  • Good organizational and interpersonal skills
  • Attention to detail.
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as RealTime)