Project Manager, Clinical Research-Neuroscience

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Job Summary:

Key Position Details:

This Project Manager role will provide support for research teams at Allina Health Neuroscience, Spine, and Pain Institute (AHNSPI) and Mental Health and Addiction Services (MHAS). The AHNSPI/MHAS research team supports three hospital sites, and more than 19 physician investigators. The primary location will be Abbott Northwestern and will include occasional travel to United and Mercy hospital campuses to meet with staff and providers.

• Full-time position
• 8-hour, day shifts
• No weekend rotation

Job Description:

Provides strategic and operational expertise for ethical conduct of clinical research trials and investigator initiated studies including all aspects of the research process. Coordinate clinical research studies, moving them through the regulatory and contractual process, initiating the feasibility and start-up process, providing guidance and tools for conducting the studies and working with the appropriate staff to complete the Institutional Review Board document submission and updates.

Principle Responsibilities

• Oversees conduct of clinical research studies.
  • Work closely with Research Director and Medical Director and stakeholders to develop and manage the departmental research portfolio to include billing and budget process.
  • Initiate the feasibility and study start-up process for new research studies.
  • Move research studies through the regulatory and contractual process and report progress.
  • Arrange and prepare for pre-study visits, site initiation visits, interim monitoring/auditing visits, and study close out activities.
  • Work with Regulatory Specialist to complete regulatory and Institutional Review Board document submissions and updates.
  • Provide guidance and tools for study conduct - assists the study coordinators in setting up investigational product tracking systems, documentation templates, and study checklists.
  • Assist in the development of study specific order sets for study-related protocols and amendments.
• Participate in training and mentoring of research and clinical staff for protocol specific procedures and regulatory requirements.
  • Train department and hospital staff on study related protocols, and procedures and document training activities to ensure competence in conduct of research activities.
  • Provide ongoing oversight/mentoring to ensure compliance with all research regulations.
  • With support from Regulatory Specialist, assist Research Departmental Leaders in developing and maintaining departmental policies/procedures and work standards.
  • Demonstrate understanding of research regulatory requirements and works with Research Director to develop a plan to maintain compliance with all regulatory agencies. .
  • Provide orientation and mentoring to new research staff including research nurses, clinical research coordinators and other research staff.
• Other duties as assigned.

Required Qualifications

• Bachelor's degree in Life sciences or related field or
• Bachelor's degree in Nursing from accredited program
• 2+ years experience in clinical research

Licenses/Certifications

• Licensed Registered Nurse - MN Board of Nursing required if applicable if Bachelor's degree in nursing) upon hire
• Certified Clinical Research Coordinator upon hire preferred or
• Certified Clinical Research Professional upon hire preferred

Physical Demands

• Sedentary:
• Lifting weightUp to 10 lbs. occasionally, negligible weight frequently