YCCI Manager, Ancillary Services

Yale Center For Clinical Investigation Manager

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Salary Range $68,000.00 - $120,500.00

Overview

The Yale Center for Clinical Investigation (YCCI) Manager, Ancillary Services is principally responsible for the support of the Ancillary Services provided by YCCI in the support of Yale faculty clinical research. Ancillary Services: clinical research support lab, food services, transport, and clinical operations on clinical trials across all Yale campus', including the dedicated research locations at the 20 York Street, 2 Church Street South, West Campus, or that conducted at any appropriate deemed clinical location across the Yale Medicine or Yale New Haven Health System delivery locations. Trial types include federally-funded, foundation, industry-sponsored, and investigator initiated human subject research.

This position is responsible for operations management, financial planning, budgeting and service billing, strategic planning, personnel management, regulatory compliance, facilities planning, and technology deployment in all existing and future Research Ancillary Services across the enterprise. Manages and directs the ongoing and day to day operations of the Ancillary Services staff deployed to serve the entire clinical network, including the dedicated research clinical locations of the YCCI CRSU; YNHH HRU, MRRC and West Campus and other sites implemented as part of the YSM/YNHH clinical research expansion plans for research conducted at any appropriate deemed clinical location across the Yale Medicine or Yale New Haven Health delivery locations. Oversees the strategic deployment of resources among lab and other ancillary service locations reporting to the YCCI Associate Director of Clinical Operations.

In addition, this position is a critical partner in human subject's research strategy relevant to all areas of research with other entities at Yale such as the Smilow Cancer Center, the Human Research Protection Program, the Office of Sponsored Programs, and Yale New Haven Health.

Required Skills and Abilities:

1. Assesses research laboratory, food services, transport and equipment and staffing needs and capabilities at all locations and recommends/implements actions and improvements needed to ensure optimal compliant functioning of the existing research labs.

2. Manages personnel to ensure optimal performance, evaluation of performance, and attainment of Research Ancillary Services objectives in support of Yale clinical trial research at all Yale University/Yale Medicine and Yale New Haven Health system locations.

3. Ensures compliance is established and met at all clinical locations.

4. Assesses, plans, and implements Ancillary services for new locations within the YCCI network of sites or Yale University/Yale Medicine and Yale New Haven Health system clinical locations.

5. Interfaces and partners with existing clinical and regulatory resources within the YCCI to ensure the delivery of high performance clinical trials at Yale.

Preferred Skills and Abilities:

1. Master's degree in relevant field preferred; experience in clinical research preferred.

2. Extensive knowledge of CLIA laboratory standards and Good Manufacturing Practices (GMP) standards as demonstrated through past experience and management.

Principal Responsibilities:

1. Evaluates the effectiveness of clinical operational procedures and makes or recommends changes to facilitate the highest level of patient service and access. Identifies issues that impede delivery of quality patient access; develops and implements short-term improvements and plans for long term process improvements. Partners with members of the leadership team to develop long term objectives for the practice related to access productivity, compliance, communication and patient satisfaction.

2. Monitors and analyzes monthly clinical statistics and key productivity and patient satisfaction indicators to assess accuracy and effectiveness of processes, and identifies trends or items requiring immediate corrective action.

3. Monitors and enforces compliance with existing policies and procedures, Practice Standards, HIPAA regulations and other compliance standards throughout all clinical activities. Develops budgetary forecasts.

4. Oversees the monitoring and enforcing of customer service standards for staff members addressing deficiencies. Resolves patient service and clinical issues by interfacing with clinic staff, YNHH, YMG management, faculty and other clinical operations managers.

5. Oversees clinical operations of section by ensuring appropriate staffing, training, ongoing education, and monitoring of day-to-day activities. Approve and monitor all personnel functions including staff schedules, payroll, time-off, and attendance and lunch schedules; arrange appropriate coverage.

6. Directly monitors patient throughput in real time to ensure effectiveness, efficiency and safety are priorities in moving patients through their clinical visits. Makes on the spot adjustments to improve throughput when necessary.

7. Works with the clinical leadership and other key departmental clinical/administrative staff on matters relating to practice performance and clinical issues in accordance with budget, goals and benchmarks. Provides leadership and direction to clinical staff where appropriate.

8. Researches and develops proposals for internal and external program initiatives and new administrative and clinical opportunities and advises leadership on the impact of new projects or initiatives. Prepares special analyses, reports and complex modeling to support the decision-making process. Analyzes proposals and determines cost, benefits, risks and liabilities.

9. Streamlines communications between EMR, team, physicians, and clinical staff. Establishes, implements and monitors medical record protocols and procedures. Ensures office compliance with Federal/state/local regulations.

10. Monitors clinician work schedule assignments for best utilization of space, maximum productivity, and adherence to clinic session guidelines. Builds templates and performs maintenance on schedules as necessary.

11. Represents area with regard to facility concerns, maintenance and security.

12. Keeps current in clinical management and process improvement concepts through involvement in professional organizations, seminar attendance, user group meetings and individual research.

Required Education and Experience

Bachelor's degree in relevant field and 2 years of related experience; or an equivalent combination of education and experience.

Location

2 Church Street South, New Haven, Connecticut