Title: Director of Clinical Research
Company: The Retina Partners
Location: Encino, CA
In this role you are responsible for our Ophthalmology Clinical Research Department, including development and execution of key strategies that support study excellence and growth as well as management of a team of study coordinators.
• Provide research oversight and direction to the execution of all trials
• Establish productivity expectations and make recommendations regarding staffing
• Monitor patient enrollment, monthly reporting
• Build/manage internal and external relationships
• Problem solve clinical situations with staff and physicians/Administrator
• Oversee/manage day-to-day needs of department
• Oversee study start-up activities, regulatory compliance, and monitor study coordinator activities including effective management of research patients per protocol and accurate and timely data collection (must have knowledge with site feasibilities, IRB submissions, regulatory documentation for startup activities, SIV and COV)
• Review, negotiate, and approve confidentiality agreements, master study agreements, clinical trial agreements, vendor service agreements
• Negotiate budgets to capture administrative and study-related costs.
• Primary point of contact for study sponsors, CROs, and vendors
• Strong fiscal management including billing, invoicing, financial reconciliation, and reporting
• Schedule and host PSVs, SIVs, and arrange study monitor visits
• Develop/implement standard operating procedures (SOPs) to ensure compliance with federal, state, and local regulations and Good Clinical Practice (GCP) guidelines governing conduct of clinical research in human subjects.
• Other tasks as assigned.
Experience:
• BA/BS preferably in sciences or equivalent combination of experience.
• Must have>3 years Clinical Research experience (ophthalmology preferred)
• Knowledge/experience with GCP/ICH and local regulations
• Experience in web-based data collection applications
• Strong communication skills
• Excellent organizational skills/attention to detail
• Ability to manage, prioritize, and report progress on multiple projects/tasks
• Ability to build and manage teams, organize, delegate, and encourage individual/departmental success
• Strong skills in building and maintaining relationships