Clinical Research Nurse - Department of Medicine Clinical Research Unit - Grant Funded

Carilion Clinic•Roanoke, VA

About The Position

The Clinical Research Nurse IV manages clinical and administrative activities associated with the conduct of research studies including industry sponsored, grant funded or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D. Recruit, screen, and enroll eligible study participants. Obtain informed consent from study participants. Manages completion and submission of study related documentation. Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance. Assist in monitoring enrollment goals. Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team. Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Collect, process, and ship research specimens as directed in the protocol. Ensure compliance with study protocol and requirements of regulatory agencies. Tracks and reports adverse events and protocol deviations. Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure. Prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence. Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log. Within the scope of their license, perform patient related care independently. Provides in-depth clinical research training and mentorship to junior and intermediate CRC/Ns. Contributes to trial planning, development, and implementation activities. Provides education and support throughout the research process to all members of the research team and to ancillary departments involved in research. Assists with protocol feasibility determination, identifying potential barriers and proactively solving problems. Assists in developing data collection systems and compiling study-related reports. Assists in writing research grant proposals, manuscripts, study materials, brochures, and correspondence. Acts as a champion for clinical research at Carilion Clinic. The individual must operate independently and exercise judgment in task prioritization. Must exercise flexibility in schedule in order to meet various deadlines. Must maintain confidentiality. Must work accurately, with attention to detail. Functions as a liaison with principal investigators, other investigators, study sponsors, and institutional departments; prioritize and process information between the groups. Must be forward thinking and strategic, with ability to quickly learn new information and adapt to changes in priorities and assignments. This job description is only meant to be a representative summary of the major responsibilities and accountabilities performed by the incumbents of this job. The incumbents may be requested to perform job-related tasks other than those stated in this description.

Requirements

Bachelor degree in biology or medical/clinical sciences (i.e. physiology, nursing, etc.), or a related field required.
Graduation from an accredited nursing program required.
FDA knowledge required.
Minimum of fifteen (15) years of Clinical Research (or equivalent research experience) and a Bachelor Degree in Science required.
License or certification specific to the discipline according to Virginia requirements.
Current license to practice as a Registered Nurse in the Commonwealth of Virginia required.
Nationally recognized clinical research certification from Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) required upon hire.
I.A.T.A. (International Air Transport Association) certification is required for projects that will be transporting specimens prior to completion of IRB application.
Thorough knowledge of medical terminology and human anatomy and physiology.
Working knowledge of the disease/condition under study, the clinical trial process and good clinical practices.
Proficient in the application of federal regulations and the Good Clinical Practices governing clinical research.
Must be competent in word processing and spreadsheets.
Proficient with data base management systems and statistical software, research methodology, and statistical analysis.
Must have effective interpersonal and problem-solving skills.
Must be self-directed and excel in attention to detail.
Must use good judgment with regard to priorities and deadlines.
Must have demonstrated leadership among a research team.

Nice To Haves

Masters Degree preferred.

Responsibilities

Manages clinical and administrative activities associated with the conduct of research studies
Serves as liaison between research sponsors, site management organizations, local Institutional Review Board (IRB), physicians/staff, and R&D
Recruit, screen, and enroll eligible study participants
Obtain informed consent from study participants
Manages completion and submission of study related documentation
Communicates with research sponsor or CRO, local or central IRB, Research and Development, and other ancillary departments to ensure smooth implementation of research protocol and ongoing maintenance
Assist in monitoring enrollment goals
Coordinates tasks such as developing informed consents and screening materials, scheduling visits, and acting as a liaison between research participants and the research study team
Collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources
Collect, process, and ship research specimens as directed in the protocol
Ensure compliance with study protocol and requirements of regulatory agencies
Tracks and reports adverse events and protocol deviations
Coordinates all site related monitoring or auditing visits from sponsor or federal agency during the course of the study and at closure
Prepares, submits, and maintains IRB, R&D, FDA and/or any other funding or regulatory documents and research correspondence
Develops and maintains patient databases and study maintenance logs including but not limited to training logs, delegation of responsibility logs, screening logs, enrollment logs, and investigational product log
Within the scope of their license, perform patient related care independently
Provides in-depth clinical research training and mentorship to junior and intermediate CRC/Ns
Contributes to trial planning, development, and implementation activities
Provides education and support throughout the research process to all members of the research team and to ancillary departments involved in research
Assists with protocol feasibility determination, identifying potential barriers and proactively solving problems
Assists in developing data collection systems and compiling study-related reports
Assists in writing research grant proposals, manuscripts, study materials, brochures, and correspondence
Acts as a champion for clinical research at Carilion Clinic