Research Project Specialist

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Job Summary:

Key Position Details:

Experience with Epic Electronic Medical Record preferred

- Certified Nursing Assistant a plus

• 1.0 FTE (40-hours per week schedule)
• 8-hour day shift
• No weekends

Job Description:

Provides leadership in the clinical research department for clinical trials study activities including patient enrollment and assessments, data management, study material preparation, regulatory document preparation, and project coordination 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 Management Activities
  • Screens electronic medical records to identify potential study participants based on protocol inclusion and exclusion criteria.
  • Independently conducts and documents the informed consent process with potential research subjects in accordance with research standards of practice (SOP) and Institutional Review Board requirements.
  • Develops, implements, and evaluates the patient's plan of care based upon patient and family assessments.
  • Completes all study-related activities including diagnostics, quality of life assessments, and laboratory procedures. Performs study activities and assessments within the scope of training and certification.
  • Independently manage source documentation and accurately record data in case report forms for each study participant during the study.
  • Communicates with principal investigator, research staff, clinical care teams, and sponsor regarding patient care issues and study progress.
  • Prepares for study monitoring and audit visits and meet with monitor/auditor to resolve any discrepancies.
  • Oversees study close-out and archiving of study data in accordance with research SOPs.
• Research Study Start up.
  • Collects essential regulatory documents and facilitate Institutional Review Board submissions.
  • Reviews and revises Informed Consent forms to match study protocol, regulatory requirements, and local Institutional Review Board policies.
  • Collects essential regulatory documents.
  • Creates study-specific tools and develop study plan of execution.
  • Prepares regulatory documents, study materials, recruitment materials, laboratory kits.
  • Ensures all documents are in compliance with the U/S Food and Drug Administration regulations.
  • Educates internal and external personnel about studies; provide guidance to clinical staff regarding implementation of study protocol.
• Study Feasibility Activities
  • Evaluates new study protocols to determine feasibility at the site, target enrollment goals related to available study population, and potential budget items to perform the study.
  • Anticipates and orders special equipment and laboratory supplies for new studies.
  • Provides Radiology and Imaging Capabilities Assessment Forms and phantom images required during study feasibility.
• Data and invoice activities.
  • Performs trial related invoicing and reimbursements with system and study sponsors.
  • Maintains study database and perform data extraction from electronic medical records and or/patient charts.
  • Conducts ongoing data analysis to generate interim study reports.
• Other duties as assigned.

Required Qualifications

• Associate's or Vocational degree in medical field
• 2+ years experience in research

Preferred Qualifications

• Bachelor's degree in biological sciences or related field

Licenses/Certifications

• Collaborative Institutional Training Initiative (CITI Program) Certification to be completed within 90 days of hire (offered through Allina Health)
• Certified Clinical Research Coordinator preferred
• Certified Clinical Research Professional preferred

Physical Demands

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

Pay Range

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.