Job Description
Description
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.
Requirements 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.
Job Tags
Full time, Contract work