Senior Clinical Research Coordinator, Research Supervisor

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.