CLIN RSCH SUPV 1

Job Function Summary:

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.

Generic Scope:

Provides immediate supervision to a unit or group of operational or technical employees. A portion of time may be spent performing individual tasks related to the unit; however, supervisory activities must constitute a primary part of the job.

Supervises unit operations to ensure compliance with departmental or organizational policies, procedures, and defined internal controls. Ensures accountability and stewardship of department resources (operational, financial, and human) in compliance with departmental standards and procedures.

Custom Scope:

The Department of Medicine, Division of Cardiology has developed a clinical research infrastructure within the Division. The goals are to increase industry-sponsored research, create a system that will assist a physician within the division to operationalize an investigator-initiated study, and to develop a general cardiology cohort study.

The purpose of this position is to carry out the needed tasks as a part of ongoing and future clinical and translational research projects in the Division of Cardiology.

The CCRU Infrastructure Supervisor reports to the Cardiology Clinical Research Infrastructure Manager. Under their direction, the Infrastructure Supervisor is responsible for assisting with hiring, supervising, and leading a team of 10-15 Clinical Research Coordinators and potentially 2-3 Senior Clinical Research Coordinators.

The Supervisor is responsible for:

• Assessing workload assignments.
• Direct oversight of data collection and reporting.
• Clinical trial management to accomplish implementation of protocols within the program that meet federal, state, and institutional policies and guidelines.
• Acting as an advisor to ensure proper training competencies have been accomplished and that overall workload can be managed safely and accurately.
• Advising the Clinical Research Infrastructure Manager of all resource allocation and data management issues.
• Working closely with the department's financial team to ensure adequate study funds are allocated and payments from study sponsors are reconciled.

Department Overview:

The Division of Cardiology is one of the largest clinical, research and training divisions of the Department of Medicine at UCSF.

The Division has developed a well-established Cardiology Clinical Research Unit, which supports 100-120 active clinical trials. The CCRU research portfolio covers:

• Phase I-IV trials
• Post-approval trial types
• Pharmaceutical research
• Device research
• Preventative research
• Social behavioral research

Within the Division are sub-specialty sections for:

• Adult Congenital Heart Disease
• Advanced Heart Failure, Transplant, and Pulmonary Hypertension
• Cardiac Electrophysiology
• Critical Care Cardiology
• Cardio-Oncology and Immunology
• Echocardiography and Cardiac Imaging
• General Cardiology
• Interventional Cardiology
• Prevention

The Division runs several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows through ACGME, as well as non-ACGME training programs.

In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, federal, and privately supported research programs, and six faculty laboratories.

The Division has:

• 90+ full-time faculty
• Several non-faculty academics
• 36 clinical fellows
• Several post-doctoral research fellows
• Approximately 60 research support and administrative staff

The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions.

While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.

Research Operations Management

• Develop project plans, interview key sponsors, and deliver tangible project results.
• Develop and update Standard Operating Procedures (SOPs).
• Design and perform ad hoc performance analysis of the projects and the project staff.
• Perform business process reviews, operational reviews, and design and implement workflows and controls.
• Develop project-related presentation materials for studies.
• Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.).

Clinical Trials Management

• Direct responsibility for delivery of key trial goals and objectives, including enrollment targets and outcome event adjudication.
• Monitor compliance with all policies and processes and adhere to established standards.
• Develop recruitment and screening strategies with study staff to ensure enrollment targets are met.
• Maintain an inventory of the status of all clinical trials on a quarterly basis to assess overall targets and outcomes.
• Ensure study documents are retained and stored onsite and offsite according to FDA guidelines when studies have closed.
• Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment.
• Lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure documentation and storage of study files meet legal requirements.
• Ensure optimal systems are in place to comply with regulatory requirements for the safe conduct of clinical research.
• Ensure all IRB documents are up to date.
• Oversee preparation of new IRB applications, arrange renewals of existing protocols, respond to IRB requests for revisions, and coordinate protocol changes with study sponsors.
• Ensure timely reporting of protocol violations to study sponsors and adverse events to the IRB.
• Respond to requests and reviews of studies from sponsors, study monitors, the FDA, and other entities, including complex audits of study performance.

Longitudinal Cohort Studies

• Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation.
• Work with leadership to ensure proper execution of studies.
• Manage activities for cohorts in various areas of studies and disciplines, and for clinical trials in various disciplines.
• Collaborate with other universities, clinical entities, and industry using collected data to understand disease progression and predictors.
• May contribute to or lead scientific presentations and publications based on study data collected.
• May contribute to the development of new grant proposals.

Risk Management

• Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws.
• Implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success.
• Act as a regulatory authority and advisor by training and educating employees and advising leadership and Principal Investigators (PIs).
• Manage audits.
• Help institute and maintain a Quality Improvement Process.

Human Resources

• Supervise staff work assignments and schedules to meet clinical research goals and timelines.
• Meet regularly with assigned staff to set goals and ensure objectives are being met.
• Directly supervise the quality and quantity of work to ensure studies meet objectives and are compliant with all regulations.
• Advise employees regarding the resolution of technical problems.
• Communicate and collaborate with cross-functional teams.
• Evaluate assigned staff performance and competency.
• Define individual development goals.
• Mentor professional staff, including employees learning a new area of clinical practice.
• Encourage assigned staff to further their knowledge through clinical education and certifications.
• Recommend salary actions, promotions, and terminations.
• Conduct necessary personnel actions, including disciplinary actions.
• Recommend changes in staffing and budget to ensure the efficient operation of the function.
• Participate in the recruitment and orientation of new employees.

Required Qualifications

• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
• In-depth knowledge of clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal, and written communication skills.
• Demonstrated project management skills with the ability to effectively manage multiple priorities, prioritize projects, and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills.
• Demonstrated management and conflict resolution skills to effectively lead and motivate others.
• Demonstrated experience in training others in the field of research.
• Strong communication skills, including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator with the ability to influence and negotiate.
• Excellent interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship. Ability to effectively motivate others, work collaboratively to achieve common goals, and cultivate relationships with multiple stakeholders at various levels of administration.
• Demonstrated ability to analyze complex and non-routine issues requiring innovative solutions.
• Demonstrated ability to operate effectively in a changing organizational and technological environment.
• Demonstrated ability to assess and respond to audit risk; ability to develop project plans and schedules and motivate teams to meet deadlines.
• Demonstrated ability to interpret and apply policies and regulations.
• Significant project and clinical trial management experience or progressively responsible experience in a related position, including regulatory and compliance responsibilities.
• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.

Preferred Qualifications

• Completion of an educational program in clinical trial management that offers certification.
• Two to three years of experience with industry clinical trials as a Clinical Research Associate (CRA).
• Prior experience in clinical research in various areas of Cardiology.
• Prior experience with UCSF, clinical trial billing, and institutional policies for study compliance and regulation.
• Prior experience working with OnCore, EPIC (APEX), and other data management systems.
• Experience in risk management regarding study subjects, federal and non-federal sponsors, and regulatory bodies.
• Experience with grant application procedures, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
• Three or more years of supervisory experience.

Required Qualifications

• Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
• In-depth knowledge of clinical trials, protocols, FDA regulations, and complex visit structures.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
• Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal, and written communication skills.
• Demonstrated project management skills with the ability to effectively manage multiple priorities, prioritize projects, and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
• Demonstrated experience managing people with a wide range of educational backgrounds and skills.
• Demonstrated management and conflict resolution skills to effectively lead and motivate others.
• Demonstrated experience in training others in the field of research.
• Strong communication skills, including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator with the ability to influence and negotiate.
• Excellent interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship. Ability to effectively motivate others, work collaboratively to achieve common goals, and cultivate relationships with multiple stakeholders at various levels of administration.
• Demonstrated ability to analyze complex and non-routine issues requiring innovative solutions.
• Demonstrated ability to operate effectively in a changing organizational and technological environment.
• Demonstrated ability to assess and respond to audit risk; ability to develop project plans and schedules and motivate teams to meet deadlines.
• Demonstrated ability to interpret and apply policies and regulations.
• Significant project and clinical trial management experience or progressively responsible experience in a related position, including regulatory and compliance responsibilities.
• Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.

Preferred Qualifications

• Completion of an educational program in clinical trial management that offers certification.
• Two to three years of experience with industry clinical trials as a Clinical Research Associate (CRA).
• Prior experience in clinical research in various areas of Cardiology.
• Prior experience with UCSF, clinical trial billing, and institutional policies for study compliance and regulation.
• Prior experience working with OnCore, EPIC (APEX), and other data management systems.
• Experience in risk management regarding study subjects, federal and non-federal sponsors, and regulatory bodies.
• Experience with grant application procedures, personnel documentation, contract generation, and subcontracting, preferably at UCSF.
• Three or more years of supervisory experience.