JOB DESCRIPTION & QUALIFICATIONS Description A Brief Overview

The System HHVI Clinical Trial Director oversees the design, development, implementation, and evaluation of clinical research, processes, and standards to improve research operations, practices, care delivery and patient experience across the HHVI and Med/Surg within the context of UH system goals. The HHVI Clinical Trial Director also provides directional guidance to staff in keeping with the GCP and FDA guidelines. The Director develops the goals, implementation of plan, and performance standards to facilitate the delivery of high-quality, safe, cost-effective, and consistent clinical research.

What You Will Do

Vision and Values • Facilitate the development of alignment, commitment, and System-wide adoption of the UHHS vision. • Ensure alignment of clinical research and educational missions within HHVI. • Establish a culture of collaboration and integration that enhances the provision of excellent patient care and patient satisfaction, and provides a safe patient care environment. • Incorporates a patient and family-centered approach that consciously incorporates/includes the patient and family’s perspective and focuses on needs as they define them. • Drive a patient-centric culture within HHVI. • Maintain strong knowledge of research policies and guidelines and understand the business impact of administrative directives. • Anticipate and act on emerging healthcare trends to position the System for the future, in conjunction with other System leaders. • Establish a culture of open communication, accountability, and timely decision-making.

System-Wide Strategy • Work closely and collaboratively with senior leaders, nursing leaders, nursing staff, and physicians across UHHS to deliver the strategy. • Collaborate to set the HHVI strategic plan, which addresses opportunities to expand/extend clinical trials and education • Execute the communications and plan provided by the HHVI President, promoting alignment between the clinical research and educational missions. • Drive a HHVI and System-driven clinical research culture across all UHHS locations. • Align HHVI clinical research strategy to System strategy. • Assures compliance with FDA & GCP, human subjects protection, and all regulatory agencies • Provides quality control and timely, accurate data submission. Works to address quality improvement opportunities

HHVI Strategy and Operations • Participate in setting direction for HHVI clinical research and advocacy arenas. • Provide direction to the operations and management of clinical education to ensure alignment with HHVI clinical research staffing plans and growth strategies, and to maintain quality and accreditation standards. Serve as a leader for clinical research workforce development to increase the visibility of research in collaboration with system leadership and HR. • Design, develop, implement and manage, standards and processes that directly improve the value of clinical research. Improve overall organizational performance, and improve clinical, service, risk, and operational outcomes in the clinical research continuum. • Develop and maintain clinical research infrastructure to enhance decision-making and decrease variance in care, quality, and safety across all locations. • Facilitate clinical best practice sharing across clinical research specialties. • Develop, implement and evaluate clinical research budgets, awards, and seek external funding. • Provide oversight for the quality of clinical research. • Accountable for professional development and growth of staff. • Develop and implement strategies to continuously improve employee engagement. • Responsible for appropriate staffing and skill to adequately administer the clinical research functions. The team consists of financial, regulatory, and clinical. • Works to manage expenses and promote new revenue or business growth opportunities • Collaborates closely with the Director of Harrington Heart & Vascular Institute as well as the Departments of Surgery and Medicine Chairs to affect the ultimate success of the Clinical Research Programs~ • Develops and maintains fiscal responsibility for all areas of supervision

Policy and Compliance • Execute clinical research-related clinical policies. • Assure regulatory standards and drive compliance across the clinical research continuum. • Enable nursing professional development and excellence. Additional Responsibilities

Performs other duties as assigned.

Complies with all policies and standards.

For specific duties and responsibilities, refer to documentation provided by the department during orientation.

Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Qualifications Education

Bachelor’s Degree (Required)

(BSN) Bachelor’s Degree in Nursing (Preferred)

Master’s Degree (Preferred) Work Experience

10+ years of experience in research (Required) and

5+ years of management experience preferably in research or ambulatory setting (Required)

Experience in research nursing (Preferred)

Experience in heart and vascular (Preferred) Knowledge, Skills, & Abilities

Demonstrated program development and budget management skills. (Required proficiency)

Prior knowledge of federal, FDA, and GCP requirements for research. (Required proficiency)

Excellent verbal and written communication skills. (Required proficiency)

Excellent personnel management skills. (Required proficiency)

Proven ability to manage large clinical research (Required proficiency) Licenses and Certifications

Registered Nurse (RN), Ohio and/or Multi State Compact License (Preferred Upon Hire)

SoCRA or Research Specific Certification (Required) and

Education in the rights of humans participating in research per certification standards set forth by Case University (Required) Physical Demands

Standing Occasionally

Walking Occasionally

Sitting Constantly

Lifting Rarely up to 20 lbs

Carrying Rarely up to 20 lbs

Pushing Rarely up to 20 lbs

Pulling Rarely up to 20 lbs

Climbing Rarely up to 20 lbs

Balancing Rarely

Stooping Rarely

Kneeling Rarely

Crouching Rarely

Crawling Rarely

Reaching Rarely

Handling Occasionally

Grasping Occasionally

Feeling Rarely

Talking Constantly

Hearing Constantly

Repetitive Motions Frequently

Eye/Hand/Foot Coordination Frequently Travel Requirements

10% Next you will be prompted to log in. Next you will be prompted to log in. LOCATION University Hospitals is a national leader in healthcare that takes pride in calling North-East, Ohio home. With more than 150 locations throughout Cleveland and the surrounding metropolitan areas, UH provides unique opportunities to deliver world-class care in the communities where our employees live, work, and play.