What are the responsibilities and job description for the Senior Clinical Research Coordinator, Research Supervisor position at Nira Medical?
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.
- 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.