RN Clinical Research

About the role

This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials in assigned area(s) of responsibility in coordination and collaboration with principal investigators. Communicates with external funding agencies, sponsors, departments, and patients to ensure understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements.

Responsibilities

• Participates in clinical trial selection with research leadership and organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required.
• Uses the nursing process to ensure protocol compliance including but not limited to patient recruitment, engaging in informed consent, patient education, & oversight of investigational drug administration schedule and conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines.
• Captures and/or supervises staff for the completion of case report forms on assigned protocols within the time frame required by the study and works in partnership with regulatory team to ensure appropriate credentialing, training, and maintenance of regulatory documents in accordance with SOP and applicable regulations.
• Oversees and/or conducts basic lab duties including centrifuging, aliquoting, and storing and shipping of study specimens.
• Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems.
• Trains less senior team members and interns and identifies his/her ongoing professional development needs and seeks resources and opportunities to meet those needs (nursing organizations, independent classes, lectures, etc.)
• Performs other related duties as assigned.

Requirements

• Education Required – Associate degree in nursing.
• Work Experience Required - 3 years of experience in area of assigned clinical specialty including 2 years performing clinical research, or 2 years of relevant research experience in a clinical setting with ACRP, SOCRA, or relevant professional nursing certification.

Qualifications

• Current registered nurse license in state of practice.
• Basic Life Support (BLS) from the American Heart Association.

Skills

• Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process.
• Working knowledge of ICH guidelines for ethical conduct of research.
• Strong problem solving and critical thinking skills and ability to work independently and in a team environment.
• Ability to follow and provide critical feedback on the investigational plan.
• Ability to train junior staff members standard operating procedures and other related research activities.
• Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques.
• Strong working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity.
• Knowledge and execution of the nursing process to assess toxicities from investigational therapies and works with the investigator in management of these adverse events.
• Working knowledge in using computers, software, and web-based applications, including working knowledge of Epic.
• Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts, shifts depending on area of assignment.

Benefits

Details about benefits are not specified in the provided job posting.

Pay

Details about pay are not specified in the provided job posting.

Schedule

Details about the schedule are not specified in the provided job posting.