Senior Clinical Research Nurse

JOB SUMMARY

A Senior Clinical Research Nurse is a member of the research team who serves participants in clinical trials with direct patient care. The essential job functions of this position requires the performance of research-related procedures and support, and establish working relationships with the providers, investigators, and research team members. This position is also responsible for high-quality care and assessments of patients participating in clinical trials for assigned studies.

RESPONSIBILITIES

• Provide training and/or orientation to new investigators, nursing staff, and research team members on research expectations and study-specific topics and requirements, as requested. 
• Maintain a culture of compliance and productivity, inclusive of adherence to training and licensure requirements, as requested.
• Collaborates with site physicians to assist in the integration of clinical research and clinical care.
• Collaborates with and/or directs research team members to ensure research studies are integrated with clinical workflows at the Site, as necessary.
• Design and develop strategies for outreach to patients and physicians, as appropriate to meet or exceed performance expectations.
• Perform and adhere to clinical functions commensurate with pertinent nursing license scope of practice (i.e., keep within state Board of Nursing scope of practice for license as an LPN, RN, etc.)
• Maintain compliance with required hospital and unit-specific training competencies as well as an active nursing license status with the state Board of Nursing
• Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow-up, collect patient/ research participant history, collect, and maintain source documentation, perform data entry, and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
• Under the supervision of an investigator, conduct health assessments as medically necessary or required per protocol to assess or resolve adverse events, safety, and general health of study participants.
• Monitor study participants for adverse events and report any adverse events to the principal investigator, and study coordinator, if applicable.
• Administer study interventions and treatments as directed by the principal investigator, if appropriate for scope of license.
• Prepare and monitor administration, usage, and documentation of investigational products and other required treatments in clinical trials.
• Perform diagnostic tests and monitor participants’ health through regular assessments.
• Observe, document, and report any changes in participant’s health status, and provide clinical care where necessary.
• Respond to emergencies and provide medical care as necessary and/or directed by a study investigator.
• Maintain frequent communication with research staff regarding enrollment and tasks.
• Assist with and/or perform the informed consent process of research subjects, if appropriate for scope of license.
• Support and advocate for the safety of research subjects.
• Collect, process, and ship laboratory specimens.
• Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
• Performs additional duties as assigned.

 QualificationS

• Valid nursing license in the state of employment, e.g., Registered Nurse license (RN), licensed practical nurse (LPN), etc.
• Certified as a clinical research coordinator, and/or obtain within a year

• BLS required