Project Manager-Clinical Research

Allina Health • Minneapolis, MN

1d • $41 - $57

About The Position

Allina Health is seeking a Project Manager-Clinical Research to support the Allina Health Cancer Institute Research Program. The role provides strategic and operational expertise for the ethical conduct of clinical research trials and investigator-initiated studies throughout the research process. The Project Manager coordinates studies through feasibility, start-up, regulatory, and contractual processes; provides guidance and tools for study conduct; and works with appropriate staff on Institutional Review Board submissions and updates. The position collaborates with research leadership and stakeholders to manage the departmental research portfolio, including billing and budgets, and provides training, mentoring, and compliance oversight to research and clinical staff. Occasional travel to the United, Mercy, and West Health research sites is expected; mileage reimbursement is eligible.

Requirements

• Bachelor's degree in Life Sciences or a related field, or a bachelor's degree in Nursing from an accredited program.
• At least 2 years of experience in clinical research.
• Licensed Registered Nurse through the Minnesota Board of Nursing upon hire, if applicable for candidates with a bachelor's degree in nursing.

Nice To Haves

• Certified Clinical Research Coordinator upon hire preferred.
• Certified Clinical Research Professional upon hire preferred.

Responsibilities

• Oversee the conduct of clinical research studies.
• Work with the Research Director, Medical Director, and stakeholders to develop and manage the departmental research portfolio, including billing and budget processes.
• Initiate feasibility and study start-up for new research studies.
• Move research studies through regulatory and contractual processes and report progress.
• Arrange and prepare for pre-study visits, site initiation visits, interim monitoring and auditing visits, and study close-out activities.
• Work with the Regulatory Specialist to complete regulatory and Institutional Review Board document submissions and updates.
• Provide guidance and tools for study conduct, including helping study coordinators set up investigational product tracking systems, documentation templates, and study checklists.
• Assist in developing study-specific order sets for study-related protocols and amendments.
• Participate in training and mentoring research and clinical staff on 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 research activities.
• Provide ongoing oversight and mentoring to support compliance with research regulations.
• Assist Research Departmental Leaders, with support from the Regulatory Specialist, in developing and maintaining departmental policies, procedures, and work standards.
• Demonstrate understanding of research regulatory requirements and work with the Research Director to develop a plan for maintaining compliance with regulatory agencies.
• Orient and mentor new research staff, including research nurses, clinical research coordinators, and other research staff.
• Perform other duties as assigned.

Benefits

• Medical and dental coverage.
• PTO and time away.
• Retirement savings plans.
• Life insurance.
• Short-term and long-term disability.
• Voluntary benefits, including vision, legal, and critical illness coverage.
• Tuition reimbursement or Continuing Medical Education, as applicable.
• Student loan support benefits to help navigate the Federal Public Service Loan Forgiveness Program.
• Well-being resources, including well-being dollars, dedicated well-being navigators, programs, activities, articles, videos, personal coaching, and tools.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level