Clinical Research Specialist

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Job Summary:

Key Position Details:

• 1.0 FTE (80 hours per two-week pay period)
• 8-hour day shift
• No weekends
• Will work at Abbott Northwestern Piper Building & West Health Plymouth
• Oncology experience preferred

Job Description:

Provides multifaceted support to the clinical research department in clinical research department in the clinical trials study activities. Provides 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

• Studies Feasibility Activities - in conjunction with research manager and team.
  • Evaluates overall feasibility of the study at the clinical research center and identify budget items needed to perform the study.
  • Evaluates new study protocols: Assesses protocol criteria to determine target enrollment goals related to patient population.
  • Determines and orders special equipment and laboratory needs for new studies.
  • Completes Radiology and Imaging Capabilities Assessment Forms.
• Studies Start-Up Activities - with research team.
  • Prepares and participates in site qualification visits and site initiation meetings.
  • Collaborates on developing study plan of execution.
  • Assists with recruitment strategies to enhance study enrollment.
  • Creates study-specific tools and materials for protocol implementation.
  • Collaborates with team members in preparing regulatory documents, study materials, laboratory kit supplies, informed consent forms, and recruitment materials.
  • Educates internal and external personnel about studies; provide guidance in implementing study protocols.
• Studies Management Activities.
  • Screens medical records for potential study participation based on protocol inclusion and exclusion criteria.
  • Conducts and documents the informed consent process with potential research subjects in accordance with SOPs and Institutional Review Board (IRB) requirements.
  • Develops, implements, and evaluates plan of care based upon individual patient and family assessment.
  • Utilizes appropriate procedures, interpreters, forms, etc. for patients with special communication needs.
  • Evaluates study participants and complete all study-related activities including diagnostics, and laboratory procedures.
  • Performs study-related activities and assessments within the scope of training and certification.
  • Manages source documentation and accurately report data in case report forms for each study subject during the study.
  • Ensures all data is entered within sponsor-specified parameters. Resolve queries within the sponsor-specified time periods.
  • Serves as liaison with principal investigator, research staff, clinical care team, and sponsor regarding patient care issues and progress on the study.
  • Communicates about study with the study staff and sponsor regarding patient care issues and study progress.
  • Prepares for study monitoring and audit visits.
  • Oversees study close-out visits.
• Assists and Collaborates.
  • Assists with lab kit receipt, storage and preparation, ECG monitoring, sending imaging for central review, and preparing and sending lab specimens to central laboratories.
  • Collaborates with members of the research team to ensure the proper collection, processing and shipment of pathology and laboratory specimens.
  • Communicates 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

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 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

• 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.