Clinical Research Nurse

Performs nursing duties in conjunction with clinical research studies.

• Coordinating patient care for research patients
• 
  
  • Perform/update patient medical histories
  
  

o Perform various nursing functions including blood draws, ECGs, vital signs and administer shots. Obtain and document patients' blood pressure, weight and height.

• 
  
  • Provide patients with information on research protocols and informed consents.
  • Provide support to physicians by fielding patient calls, evaluating patient information, and applying appropriate nursing judgment according to patient needs.
  
  
• Manage documentation in compliance with FDA regulations.
• Manage study supplies, including laboratory supplies and medications.

Perform pre-study duties necessary to start a clinical trial.

• Understand the purpose, safety, confidentiality, benefits, and risks of clinical research trials.
• Assess protocol for site operational feasibility and advise on site budgetary requirements.
• Prepare for and conduct pre-study (site selection) and initiation visits.
• Coordinate investigational staff and other disciplines (MRI, EKG, Lab, etc.) involved in studies.
• Complete and submit the required regulatory documents to the IRB.
• Maintain verbal and written communication with Institutional Review Boards.
• Develop and complete documentation in compliance with research protocol.
• Screen and recruit patients for clinical research trials.

Manage multiple ongoing clinical trials.

• Assure adherence to study-specific requirements.
• Organize receipt, storage and return of study supplies, including study drug, and maintain accurate accountability logs as appropriate.
• Schedule and conduct patient appointments as required by research protocol.
• Abstract relevant study information from patients' medical records.
• Perform clinical laboratory and EKG services as required by the research protocol.
• Report abnormal laboratory and EKG results to the Principal Investigator.
• Develop, complete, and collect documentation in compliance with research protocol.
• Coordinate investigational staff and other disciplines (e.g. MRI, EKG, Lab) involved in studies.
• Provide education to patients under physicians' direction and assure his/her understanding.
• Complete and submit the required regulatory documents and emergent serious medical events to the IRB under direction of Principal Investigator.
• Meet with study monitors and assure query resolution as necessary or requested.
• Assure financial reconciliation against contract, including timely and accurate payment to staff and/or study subjects.
• Monitor study information and documentation for accuracy and perform the necessary corrections.
• Prepare study site for audits and inspections from the sponsor and/or FDA and respond to any findings.
• Clean and maintain exam and laboratory rooms used for patient visits.
• Monitor temperatures and equipment calibration for quality control purposes

Close out clinical trials.

* Assure query resolution as necessary on requested.

* Prepare for and conduct study closeout visits.

* Prepare study site for audits and inspections from the sponsor and/or FDA and respond to any findings.

Assist physician and/or Clinic Site Manager with patient care or administrative support duties.

* Room patients as requested or assist physician with return phone calls to patients

* Participate in practice improvements by implementing changes to procedures/workflows, identifying opportunities for improvement, and assisting with the delivery of compassionate and personalized patient care.

Education and Experience:

• Register Nurse.
• Minimum of two years nursing experience preferably in neurology.
• Experience in conducting clinical trials preferred.
• Current Minnesota Nursing License.

Knowledge, Skills, and Abilities:

• Excellent organizational skills.
• Valid Minnesota driver's license.
• Excellent interpersonal and communication skills, both verbal and written.
• Patient centered, strong customer service orientation.
• Ability to handle multiple priorities and deadlines and troubleshoot and resolve problems.
• Ability to work independently, exhibit mature judgment and make sound decisions.
• Ability to handle confidential information with the utmost judgment and discretion.
• Proficiency with MS Office, including Word, Excel and Outlook.