Senior Clinical Research Coordinator, Research Supervisor

Nira Medical

Lehi, UTFull-time

Behavioral Health Market Context

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Job Description

standing of the study, collect data using Good Documentation Practices, maintain accurate and up-to-date records of study activities.
• Communicate with study sponsors, regulatory bodies, and other stakeholders.
• Prepare and submit regulatory documents as required.
• Ensure proper storage and handling of study specimens and investigational products.
• Leadership and Mentorship:
• Lead and mentor junior research staff, providing guidance and support until mastery in needed skills is demonstrated.
• Foster a collaborative and productive work environment that encourages continuous improvement.
• Lead regular team meetings to discuss status of current projects, plan for future projects, provide updates on new company initiatives, seek feedback regarding team barriers, etc.
• Manage local team to meet/exceed quality and performance metrics, report key performance indicators to leadership team.
• Serve as a Culture Champion to support Nira’s mission and values, ensure team is compliant with SOPs and all industry standards.
• Strategic Planning and Growth:
• Develop and implement strategic plans for clinical research projects, allocate studies to the team based on bandwidth and teammate skillset.
• Drive the growth and development of the clinical research program by identifying areas for improvement and innovation while staying informed of industry advancements.
• Proactively identify/anticipate risks (strategically, operational, financial, regulatory, and reputational) that could hinder achievement of business goals.
• Conflict Resolution:
• Address and resolve conflicts within the research team and with external stakeholders.
• Mediate disputes and facilitate effective communication.
• Implement strategies to prevent and manage conflicts.

Required Skills and Qualifications:
• Education: Bachelor's degree in a scientific, health-related, or business administration field or equivalent experience. Advanced degree (e.g., Master's, PhD) is preferred.
• Experience: Minimum of 5 years of experience in clinical research, with at least 2 years in a senior or leadership role.
• Certification: Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is preferred.
• Knowledge:
• Medical terminology and clinical trial industry knowledge.
• Good Clinical Practice (GCP) guidelines.
• Skills:
• Strong organizational and time-management skills.
• Excellent communication and interpersonal skills.
• Attention to detail and ability to work independently and collaboratively.
• Problem-solving and critical thinking abilities.
• Ability to handle multiple tasks and prioritize effectively.
• Strong ethical standards and professionalism.
• Leadership and Mentorship:
• Proven leadership skills and experience in mentoring staff.
• Ability to inspire and motivate a team.
• Strategic Planning and Growth:
• Strategic thinking and planning abilities.
• Growth mindset and a commitment to continuous improvement.
• Conflict Resolution:
• Strong conflict resolution and mediation skills.
• Ability to manage and resolve disputes effectively.
• Technical Skills:
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Familiarity with Electronic Data Capture (EDC) systems and clinical trial management software, CRIO experience is preferred.

Qualifications

  • Education: Bachelor's degree in a scientific, health-related, or business administration field or equivalent experience

Benefits

    Responsibilities

    • Clinical Trial Management:
    • Oversee, coordinate, and manage multiple clinical trials from initiation to completion
    • Ensure compliance with research protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines
    • Recruit, enroll, and manage study participants throughout the entire study
    • Obtain informed consent from participants and ensure their understanding of the study, collect data using Good Documentation Practices, maintain accurate and up-to-date records of study activities
    • Communicate with study sponsors, regulatory bodies, and other stakeholders
    • Prepare and submit regulatory documents as required
    • Ensure proper storage and handling of study specimens and investigational products
    • Leadership and Mentorship:
    • Lead and mentor junior research staff, providing guidance and support until mastery in needed skills is demonstrated
    • Foster a collaborative and productive work environment that encourages continuous improvement
    • Lead regular team meetings to discuss status of current projects, plan for future projects, provide updates on new company initiatives, seek feedback regarding team barriers, etc
    • Manage local team to meet/exceed quality and performance metrics, report key performance indicators to leadership team
    • Serve as a Culture Champion to support Nira’s mission and values, ensure team is compliant with SOPs and all industry standards
    • Strategic Planning and Growth:
    • Develop and implement strategic plans for clinical research projects, allocate studies to the team based on bandwidth and teammate skillset
    • Drive the growth and development of the clinical research program by identifying areas for improvement and innovation while staying informed of industry advancements
    • Proactively identify/anticipate risks (strategically, operational, financial, regulatory, and reputational) that could hinder achievement of business goals
    • Conflict Resolution:
    • Address and resolve conflicts within the research team and with external stakeholders
    • Mediate disputes and facilitate effective communication
    • Implement strategies to prevent and manage conflicts


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