What are the responsibilities and job description for the Clinic Manager/Senior Study Coodinator position at Sunwise Clinical Research, LLC?
Senior Study Coordinator
Location: Walnut Creek, CA
Position Summary:
We are seeking a highly experienced and detail-oriented Senior Study Coordinator to oversee the execution of clinical research studies while ensuring compliance with regulatory requirements and institutional policies. This role involves managing study operations, supervising research staff, and serving as a key liaison between investigators, sponsors, and regulatory bodies. The ideal candidate has extensive experience in clinical research coordination and demonstrated leadership in managing research teams.
Key Responsibilities:
• Lead the coordination and execution of multiple clinical research studies, ensuring adherence to study protocols, timelines, and compliance standards.
• Supervise, train, and mentor study coordinators and research staff, providing guidance on study operations and regulatory requirements.
• Act as the primary point of contact for study sponsors, regulatory agencies, and internal research teams.
• Oversee participant recruitment, enrollment, informed consent processes, and data collection to maintain study integrity.
• Manage and maintain study documentation, including regulatory binders, case report forms, and adverse event reports.
• Ensure timely submissions and approvals of Institutional Review Board (IRB) applications, amendments, and continuing reviews.
• Monitor study progress, identify potential risks, and implement corrective actions as needed.
• Collaborate with finance teams to oversee study budgets, track expenses, and ensure proper invoicing for sponsor reimbursements.
• Conduct quality assurance and compliance checks to ensure adherence to Good Clinical Practice (GCP), FDA regulations, and institutional policies.
• Assist in developing standard operating procedures (SOPs) and best practices to enhance study efficiency.
Qualifications:
• Bachelor’s degree in a relevant field (e.g., life sciences, public health, nursing) required; advanced degree preferred.
• Minimum of six (6) years of clinical research coordination experience, with at least two (2) years in a management or leadership role.
• Strong knowledge of clinical trial protocols, regulatory requirements, and compliance guidelines (FDA, ICH-GCP, IRB).
• Proven ability to manage multiple studies simultaneously while maintaining attention to detail.
• Experience with electronic data capture (EDC) systems and clinical trial management software.
• Excellent leadership, problem-solving, and communication skills.
• Ability to work independently and collaboratively in a fast-paced research environment.
• Certification in Clinical Research (e.g., CCRP, CCRC) is preferred but not required.