Project Manager-Clinical Research

Location Address:

Date Posted:

Department:

Shift:

Shift Length:

Hours Per Week:

Union Contract:

Weekend Rotation:

Job Summary:

Key Position Details:

• 1.0 FTE (80 hours per two-week pay period)
• 8-hour day shifts
• No weekends
• This position will support the Allina Health Cancer Institute Research Program
• Occasional travel to our other Research Sites at United, Mercy, and West Health(eligible for mileage reimbursement)

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 weight up to 10 lbs. occasionally, negligible weight frequently

Pay Range

Allina Health is committed to adhering with all applicable local, state and federal minimum wage requirements.

Benefit Summary

Allina Health believes the best way to provide safe and compassionate care for our patients is by nurturing the passion of those who care for them. That's why we devote extraordinary resources to help you grow and thrive - not only as a professional but also as a whole person. When you join our team, you have access to a wealth of valuable employee benefits that support the total well-being - mind, body, spirit and community - of you and your family members.

Allina Health is all in on your well-being. Because well-being means something different to everyone, our award-winning program provides you with the resources you need to help you navigate your personal journey. This includes well-being dollars, dedicated well-being navigators, and many programs, activities, articles, videos, personal coaching and tools to support you on your journey.

We are focused on creating an inclusive workplace so everyone can see themselves as part of our care team. Our care teams are as diverse as the communities we serve and proud to be contributing to the mission of a leading health care organization. Our pioneering approach to well-being helps every member of our care team feel a deep sense of connection and joy in their work.

Benefits include:

• Medical/Dental
• PTO/Time Away
• Retirement Savings Plans
• Life Insurance
• Short-term/Long-term Disability
• Voluntary Benefits (vision, legal, critical illness)
• Tuition Reimbursement or Continuing Medical Education as applicable
• Student Loan Support Benefits to navigate the Federal Public Service Loan Forgiveness Program
• Allina Health is a 501(c)(3) eligible employer

*Benefit eligibility/offerings are determined by FTE and if you are represented by a union.