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.