Research Clinic Operations Administrator

Description :

The Research Clinic Operations Administrator will support the business operations in our clinical research setting and provide coordination of day-to-day activities and processes that support clinical trials, research studies, or healthcare operations.

The research clinic at KPWHRI is a medium sized (5,500 sq foot) clinic with a lab, a research pharmacy, -70 freezers, and exam and interview rooms.

Study teams conduct both FDA and non-FDA regulated clinical research trials. This role directs and manages the daily operations of the clinic in support of this research.

This role involves ensuring the clinic is running smoothly in terms of optimal use of space, maintenance and monitoring of clinic equipment, supplies, and ensuring customer experience standards are being met.

Job Summary :

Under the general direction of the Director of Clinical Research Trials, responsible for managing the daily operations of the Kaiser Permanente Washington Health Research Institute (KPWHRI) Research Clinic.

Essential Responsibilities :

• Administrative and Operational Management of the KPWHRI Research Clinic :
• Directs and manages the daily operations of the KPWHRI Research Clinic.
• Ensures ongoing compliance and adherence to KP policy / procedures, as well as other compliance, regulatory, accreditation, and institutional requirements within the Research Clinic.
• Understands and translates standards of Good Clinical Practices to Research Clinic standard operating procedures.
• Assures optimal utilization of clinic support staff, space and financial resources.
• Ensures routine maintenance and monitoring of clinic equipment as well as oversight of emergency repairs. Collaborates with building management on clinic needs.
• Ensures clinic supplies are adequately stocked for study needs.
• May provide research clinic front desk back up coverage and / or may have a regular research clinic desk coverage schedule during high-volume periods.
• Supports clinical research programs and assigned clinical trials administratively by maintaining, organizing and / or creating tracking mechanisms such as clinic billing recharge, transportation charge logs and sections of eRegulatory systems.
• May develop and manage core budgets and recharge centers associated with the Research Clinic.
• Provides consultative support on use of Research Clinic services to Investigators and project teams during project development and implementation.
• Ensures Clinic Manual of Operations and SOPs are reviewed routinely and kept up to date.
• Supervision and Training :
• Provides matrixed supervision to clinic support staff.
• Assures that clinic support staff deliver a consistent customer experience.
• Assures comprehensive orientation, training, and education of project teams working in the Research Clinic.
• Establishes processes to monitor and support staff working in the Clinic in maintaining clinical standards and compliance training in accordance with KP, local, state and federal requirements.
• Assures that clinic support staff and project teams working in the clinic are trained and know what is expected during and after an emergency.
• Other :
• Develops long-term operational plans for the Research Clinic and the performance of clinical research as guided by the KP and KPWHRI plans.
• May lead or serve on standing committees or work groups in support of key strategic goals, and or improvement or regulatory initiatives.
• Organization of KPWHRI staff flu shot clinic.

Basic Qualifications : Experience

Minimum three (3) years of business operations experience in a clinical or clinical research setting.

Education

Bachelors degree in business, healthcare or a related field OR a minimum of four (4) years of experience in a directly related field.

High School Diploma or General Education Development (GED) required.

License, Certification, Registration

Basic Life Support required at hire

Additional Requirements :

• Excellent oral and written communication skills and knowledge of office management skills.
• Excellent program management, individual and team building skills.
• Excellent organizational, time management, workflow and planning skills.
• Outstanding problem-solving skills.
• Strong organizational skills to set up systems, monitor timeliness of workflow, and completion of work.
• Ability to prioritize and take actions in the absence of clear direction is required.
• Ability to provide excellent customer service.
• Demonstrated ability to manage multiple tasks simultaneously.
• Able to prioritize and effectively anticipate and respond to issues as they arise.
• Ability to work effectively with investigators, administration and research project management staff (e.g., different groups of people) and interdisciplinary collaboration.
• Proficiency with Microsoft Office suite; understanding of medical terminology; ability to work independently as well as part of a team;

ability to direct, coach, and train staff.

Preferred Qualifications :

• Knowledge of clinical operations and functions and / or other health organizations.
• Knowledge of clinical research regulatory requirements, ICH and best practices in implementing Good Clinical Practices.
• Knowledge of Federal and State regulatory requirements around operations of clinical settings.
• Demonstrated ability to effectively supervise and train technical and research staff.
• Experience in developing and deploying training programs.
• Experience with managing clinical research in clinics, hospitals and clinical settings.
30+ days ago