Job Description

Key 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.

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.

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