Clinical Research Unit Implementation Lead/Hybrid - 137363

This position will work a hybrid schedule which includes a combination of working both onsite on campus and remote.

The Office of the Senior Associate Vice Chancellor (SAVC) of UC San Diego Health Sciences provides oversight, assistance and support to units that that facilitate clinical research. SAVC houses a diversity of professionals and faculty that perform organizational and infrastructural support to the patient-facing clinics that run clinical trials - harmonizing efforts to support UCSD's mission to reduce health inequities.

The Health Sciences Office of Clinical Research (OCR) will collaborate with clinical investigators to uphold quality, strengthen compliance, streamline process, and establish best practices in research conduct, while ensuring that all investigators have the necessary infrastructure and support for clinical research activities.

Clinical Research Transformation (CRT) offers a wide range of consultative services, project management expertise, and business system support to Clinical Research Units (CRU) in collaboration with OCR. This includes process improvement, workflow automation, data analytics & system administration.

This position, administratively part of Clinical Research Transformation (CRT), partners with leadership and faculty to design and implement core infrastructure in collaboration with the Office of Clinical Research (OCR) to establish and develop Clinical Research Units (CRU) across UCSD. It provides solution-oriented recommendations that align with organizational goals and strategic planning efforts. The role emphasizes fostering faculty and staff engagement across all teams within the OCR, applying change management principles to support the office's strategic objectives.

Independently review, develop, and implement SOPs to streamline CRU operations, leveraging organizational consulting practices to address moderate to complex organizational issues. Define and optimize workflows for licensed and unlicensed clinical spaces to ensure regulatory compliance, applying good judgment in selecting methods and techniques for obtaining solutions

Evaluate and implement tools such as Harvest and Monday.com for time tracking and workload management, ensuring alignment with strategic organizational consulting practices. Configure CTMS workflows to enhance participant registration and tracking processes, demonstrating proficiency in identifying and resolving organizational issues. Develop and deploy a system to monitor study activation timelines, identifying opportunities for improvement and ensuring solutions are tailored to the diverse scope of CRU operations.

Create standardized communications and guidance documents for staff and investigators to ensure consistent understanding of CRU processes, applying organizational development principles to address organizational effectiveness issues. Implement a comprehensive strategy for disseminating updates, directives, and policy changes, demonstrating good judgment in selecting methods for effective communication. Other duties as assigned.

• Seven years (7) of related experience, education/training, OR a Bachelor's degree in a related area plus three (3) years of experience and/or equivalent experience/training.

• Has thorough knowledge of the organizational development and effectiveness field, theories, models to assess, design and implement customized organizational interventions.

• Demonstrates analytical, problem-solving, project planning and implementation skills.

• Skilled in facilitation, consulting and relationship building.

• Possesses effective verbal and written communication skills.

• Demonstrates ability to learn quickly, reason, synthesize and generalize based on information obtained.

• Ability to focus on priorities, strategies, and vision.

• Ability to coach, facilitate, and influence people.

• Advanced analytical/problem-solving skills.

• Demonstrated ability to respond and adapt to new and changing situations

• Demonstrated knowledge of change management theory

• Strong project management and problem-solving skills

• Demonstrated knowledge of workflow management systems (Monday.com)

• Demonstrated knowledge of Clinical Trials activation pipeline at UC San Diego

• Understanding of Clinical Trials policy and best practices at UC San Diego

• Familiarity with clinical trials processes and workflows

• Understanding of regulatory compliance requirements for clinical trials (IRB guidelines)

• Proficiency in using Velos/CTMS for managing study data, participant tracking, reporting, generating reports for decision making

• Job offer is contingent upon satisfactory clearance based on Background Check results.

• Occasional evenings and weekends may be required.