Job Summary: 

• Take leadership of all clinical operations and quality aspects of therapeutic studies by following ICH/GCP guidelines.
• Developing, drafting, and amending the Clinical Monitoring Plan
• Collaborate with cross-functional teams to ensure timelines, resources, interactions, and quality are being properly executed.
• Overseeing CRAs including mentoring, training, reviewing trip reports, signing off on monitoring visits
• Working directly with sponsors and sites to provide clinical progress updates and ensure timelines are being met
• Performed all related processes in the planning and execution of clinical studies (interventional and non-interventional), bioavailability, bioequivalence (clinical, analytical and statistical stages), pharmacodynamics and pharmacokinetic interactions to submit them to the regulatory level. 
• Support with the reporting of adverse events and comply with technical, regulatory and marketing requirements of the studies conducted.
• Ensuring related activities of clinical studies are executed following all relevant processes, SOPs, ICH-GCPs and applicable regulations.
• Works with the Performance Improvement Department to initiate and perform audits of data to ensure integrity and confidentiality are maintained. 
• Work with the appropriate departments to design/modify clinical operational procedures to maintain quality care and improve outcomes.
• Develops policies, procedures, or processes and guides the impact of regulation as it affects clinical applications and subsequent documentation.

Skills on Resume: 

• Clinical Operations Leadership (Hard Skills)
• Clinical Monitoring Plan Development (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Management and Mentoring of CRAs (Hard Skills)
• Stakeholder Management (Soft Skills)
• Clinical Study Execution (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Quality Assurance and Auditing (Hard Skills)

Job Summary: 

• Provide mental health and risk assessment of 1:1 cases and short-term psychological interventions
• Facilitate and manage therapeutic group intervention program
• Promote CYP IAPT principles
• Take part in research being conducted and develop school staff and other professionals to develop collaborative best practices across the organization and Child and Adolescent Mental Health services nationally
• Provide clinical supervision and expertise to low-intensity clinical team members
• Direct and coordinate the development of clinical reports by acting as a technical resource for the development of reports in coordination with the MIS department. 
• Design and maintain clinical support and operations manuals.
• Coordinate clinical system procedures with Finance, Revenue and Reimbursement personnel to ensure compliance with regulatory and Agency policies and procedures of all clinical software applications.
• Participate in user groups and task forces to enhance the clinical information systems.
• Assists in maintaining, in conjunction with the MIS Department, the hardware used by the clinical field staff including communication processes, etc.
• Coordinate and interface with appropriate Agency and department personnel to develop, test, implement and integrate new/upgraded clinical information systems.
• Take responsibility for serving as an Agency resource. 

Skills on Resume: 

• Clinical Assessment and Intervention (Hard Skills)
• Group Therapy Facilitation (Hard Skills)
• Knowledge of CYP IAPT Principles (Hard Skills)
• Research and Development (Hard Skills)
• Clinical Supervision (Hard Skills)
• Report Development (Hard Skills)
• Manual Design and Maintenance (Hard Skills)
• Clinical Information Systems Coordination (Hard Skills)

Job Summary: 

• Responsible to manage and coordinate the implementation and instruction process of clinical software system applications.
• Instruct clinical staff on software upgrades and new application systems.
• Coordinate the initial and ongoing education plans for clinical and office staff with the Education Manager. 
• Provide education for the staff under the direction of the Education Manager, and technical support for the clinical staff
• Communicate with the Clinical Managers about the progress of the clinical staff.
• Responsible for clinical systems application research, design, development and testing.
• Collaborates with the IT and other Departments to ensure all staff are trained. 
• Report any problems with the software to the Director of Management Information Systems immediately.
• Maintain current knowledge of all Agency clinical software currently in use including future releases. 
• Maintains a working knowledge of the technology currently on the market as it relates to home care clinical information systems.
• Supports report development and the interface between departments.
• Works to maintain all system clinical reference files and the clinical process flows to ensure consistent functionality, utilization and application of clinical information across assigned branches and users.

Skills on Resume: 

• Clinical Software Implementation (Hard Skills)
• Training and Instruction (Hard Skills)
• Education Planning (Hard Skills)
• Technical Support (Hard Skills)
• Communication (Soft Skills)
• Software Research and Development (Hard Skills)
• Collaboration (Soft Skills)
• System Maintenance and Knowledge Management (Hard Skills)