Clinical Research Specialist - Minneapolis, MN

Department: Neuro Research Admin · Shift: Day (United States of America) · Hours: 40 · Contract: Non-Union-NCT · Weekend Rotation: None · Job Profile Summary: Allina Health is a not-for-profit health system that cares for individuals, families and communities throughout Minnesota ...

Job description

Department: Neuro Research Admin

Shift: Day (United States of America)

Hours: 40

Contract: Non-Union-NCT

Weekend Rotation: None

Job Profile Summary: Allina Health is a not-for-profit health system that cares for individuals, families and communities throughout Minnesota and western Wisconsin. If you value putting patients first, consider a career at Allina Health. Our mission is to provide exceptional care as we prevent illness, restore health and provide comfort to all who entrust us with their care. This includes you and your loved ones. We are committed to providing whole person care, investing in your well-being, and enriching your career.

Job Description:

Provides multifaceted support to the clinical research department in clinical research department in the clinical trials study activities. Provide patient enrollment and assessments, data management, and study material preparation. Prepares regulatory documents, and coordinates project in accordance with research standard operating procedures, federal and state regulations, Institutional Review Board (IRB) requirements, and International Council on Harmonization Good Clinical Practice guidelines.

Principle Responsibilities

• Study Feasibility Activities - in conjunction with research manager and team.
• Evaluate overall feasibility of the study at the clinical research center and identify budget items needed to perform the study.
• Evaluate new study protocols: Assess protocol criteria to determine target enrollment goals related to patient population.
• Determine and order special equipment and laboratory needs for new studies.
• Complete Radiology and Imaging Capabilities Assessment Forms.
• Study Start-Up Activities - with research team.
• Prepare and participate in site qualification visits and site initiation meetings.
• Collaborate on developing study plan of execution.
• Assist with recruitment strategies to enhance study enrollment.
• Create study-specific tools and materials for protocol implementation.
• Collaborate with team members in preparing regulatory documents, study materials, laboratory kit supplies, informed consent forms, and recruitment materials.
• Educate internal and external personnel about studies; provide guidance in implementing study protocols.
• Study Management Activities.
• Screen medical records for potential study participation based on protocol inclusion and exclusion criteria.
• Conduct and document the informed consent process with potential research subjects in accordance with SOPs and Institutional Review Board (IRB) requirements.
• Develop, implement, and evaluate plan of care based upon individual patient and family assessment.
• Utilize appropriate procedures, interpreters, forms, etc. for patients with special communication needs.
• Evaluate study participants and complete all study-related activities including diagnostics, and laboratory procedures.
• Perform study-related activities and assessments within the scope of training and certification.
• Manage source documentation and accurately report data in case report forms for each study subject during the study.
• Ensure all data is entered within sponsor-specified parameters. Resolve queries within the sponsor-specified time periods.
• Serve as liaison with principal investigator, research staff, clinical care team, and sponsor regarding patient care issues and progress on the study.
• Communicate about study with the study staff and sponsor regarding patient care issues and study progress.
• Prepare for study monitoring and audit visits.
• Oversee study close-out visits.
• Assist and Collaborate.
• Assist with lab kit receipt, storage and preparation, ECG monitoring, sending imaging for central review, and preparing and sending lab specimens to central laboratories.
• Collaborate with members of the research team to ensure the proper collection, processing and shipment of pathology and laboratory specimens.
• Communicate effectively with member of the research and clinical care teams in person and at meetings.
• Other duties as assigned.

Required Qualifications

• Associate's or Vocational degree in a medical or science field
• 0 to 2 years of experience in clinical research

Preferred Qualifications

• Bachelor's degree in a medical or science field

Licenses/Certifications

• Must meet at least ONE of the requirements below
• Current BLS certification from the American Heart Association
• Current BLS certification from the American Red Cross
• Allina in-house BLS training (within 30 days of hire)
• Certified Clinical Research Coordinator preferred upon hire
• Certified Clinical Research Professional preferred upon hire
• Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within (180 days) of hire (offered through Allina Health)

Physical Demands

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

Additional Job Description:

• 1.0 FTE (80 hours per two-week pay period)
• 8-hour day shift
• No weekends
• Occasional travel to United Hospital or Allina Commons

Pay Range:

Pay Range: $29.31 to $40.17 per hour

The pay described reflects the base hiring pay range. Your starting rate would depend on a variety of factors including, but not limited to, your experience, education, and the union agreement (if applicable). Shift, weekend and/or other differentials may be available to increase your pay rate for certain shifts or work.

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 up to $100 in well-being dollars, dedicated well-being navigators, and many programs, activities, articles, videos, personal coaching and tools to support you on your journey.

In addition, Allina Health offers employee resources groups (ERGs) - voluntary, employee-led groups that serve as a resource for members and organizations by fostering a diverse, inclusive workplace aligned with the organization's mission, values, goals, business practices, and objectives. Allina Health also engages employees in various community involvement and volunteering events.

Benefits include:

• Medical/Dental
• PTO/Time Away
• Retirement Savings Plans
• Life Insurance
• Short-term/Long-term Disability
• Paid Caregiver Leave
• 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.