The Clinical Research Nurse position requires advanced knowledge and skills in clinical research and data coordination.  This position participates in the implementation of clinical research projects (all phases), including National Institute of Health (NIH) funded AIDS Clinical Trials Groups (ACTG), state-funded, industry-sponsored and investigator-initiated protocols.  S/he works closely with the medical director and leadership on data analysis and reporting for multiple agency grants.

Specific Responsibilities of the Job:

Clinical Research Coordination:

• Manages patient recruitment for participation in studies, screening and enrollment of subjects including identifying and analyzing inclusion and exclusion criteria, informed consent process, manage subject participation and follow-up, and complete study documentation including source documents, case report forms (CRFs) and queries.
• Manages adherence to study protocols as an assigned lead coordinator on one or more clinical trials.
• Performs vital signs, EKGs, phlebotomy, and may process specimen for shipment to external laboratory repositories and other related procedures as required by research trials.
• Manages regulatory documentation for assigned clinical research trials.
• Manages all aspects of study including: clinical study initiation, monitoring and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs).
• Administers investigational medications/therapies (including intravenous infusions) as directed by clinical trial protocol.
• Performs clinical nursing assessments before, during, and after administration of investigational medications/therapies to monitor for adverse reactions and ensure safety of study participant.
• Completes adherence counseling and investigational product accountability, completes study-specific source documents, participant questionnaires, and case report forms (CRFs); ensures that adverse events are documented and assessed by a study investigator in a timely manner.  

Required Knowledge, Skills and Abilities:

Job Requirements:

• Must be able to multi-task.
• Must possess excellent interpersonal, communication and documentation skills.
• Must demonstrate an ability to work well under pressure.
• Must demonstrate the ability to keep all information confidential.
• Must be able to function autonomously and collaborate with clinicians, health team members, sponsors and patients.
• Must be proficient in Microsoft Office applications (Word, Excel, Access, PowerPoint), electronic database systems, data analysis software, and literature review databases.
• Familiarity with electronic data capture (EDC), clinical trial management systems (CTMS), medical terminology, and FDA regulations is highly desirable

 Education and Experience:

• Bachelor’s of science degree in nursing.
• Minimum of 2 years of experience with medication administration via IV infusion.  
• Minimum of 1 year of clinical research experience preferred.
• Must have or be able to obtain certification in Human Subjects Protections (HSP) and Good Clinical Practice (GCP) training upon hire.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.