This position will be based on the Stanford campus and is a hybrid of working on-site and working from home, subject to operational need.

Stanford University is seeking a Clinical Trials Regulatory Manager to serve as the Emergency Medicine Clinical Research Unit’s (EM-CRU) Project and Quality & Compliance Manager. The person in this position would work closely with the EM-CRU Faculty Director, EM-CRU Director of Growth and Development, and EM-CRU Project Manager, and EM-CRU Clinical Research Manager. The EM-CRU Project and Quality & Compliance Manager will be responsible for leading the administration and regulatory compliance of clinical research within the Department of Emergency Medicine and representing the Emergency Medicine – Clinical Research Unit with external regulatory agencies, both domestic and international. The EM-CRU Project and Quality & Compliance Manager will be a critical addition to Emergency Medicine Clinical Research Unit to provide leadership and regulatory compliance oversight for multiple research studies, including federally funded clinical trials.

The EM-CRU Project and Quality & Compliance Manager will oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics. The EM-CRU Project and Quality & Compliance Manager will also design, develop, and implement tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects.

Additionally, the EM-CRU Project and Quality & Compliance Manager will be responsible for overseeing and supporting day-to-day trial operational activities as well as coordinating between the different internal and external trial leadership groups and stakeholders. The Project and Quality & Compliance Manager will develop Gantt charts and operational plans to coordinate key activities including trial start-up, staff training across the organization, monitor day-to-day study execution, recruitment and enrollment activities, oversee study staff across all functions and locations, and manage the study budget.

The EM-CRU Project and Quality & Compliance Manager position will be an internal facing with an emphasis on regulatory and protocol compliance across the entire EM-CRU research portfolio. Specifically, this person will 1) engage with physician-investigators to provide regulatory consultation for their research projects or clinical trials, 2) design, develop, and implement tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects, 3) oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics, 4) assist in the development of EM-CRU project management and regulatory compliance procedures and policies, and 5) develop relationships with internal and external partners as warranted.

The objective is for the EM-CRU to be a service to the School of Medicine and Stanford Health Care community for early phase adult and pediatric patient enrollment occurring during the emergence care phase of their contact with the clinical environment. This includes developing and maturing the logistics of follow up beyond an emergency department visit or contact prior and enabling the department to be a nimble collaborator with industry.

Duties include:

Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects.Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics.Lead efforts, authorize and manage submissions to internal and external agencies. Provide final review and approval for submissions and reports.Hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance. Oversee, develop and facilitate educational and compliance training programs.Educate research staff on established policies, processes, and procedures.Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance. Serve as a regulatory point of contact during audits. May act on behalf of Senior Management in regard to interactions with regulatory agencies.Represent department or institute in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the National Institutes of Health. Interact and advise senior management on clinical trials regulatory processes or decisions.Supervise the implementation of and adherence to study protocols.Organizing all aspects of meetings and committees. Overseeing meetings and review the status of the timelines, milestones, and metrics; changes in scope of work; budgeted versus actual expenditures; and key issues or problems.May have budget responsibility for day-to-day operations. May direct and/or supervise staff.

* - Other duties may also be assigned.

DESIRED QUALIFICATIONS:

Experience in clinical research management and oversight, including project management in a dynamic research setting. Experience in a lead role and interactions with federal agencies, i.e. FDA.Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice. Knowledge of International Conference on Harmonization (ICH) standards.Experience in developing and implementing multifaceted projects.Experience with MS Office products and database applications required. Strong written and verbal skills.Excellent communication and organizational skills and superb attention to detail.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.Demonstrated creativity, problem solving, critical analysis, initiative, judgment and decision-making skills.Demonstrated ability to develop and meet budget goals.Demonstrated solid planning and organizational skills.Demonstrated experience working independently and as part of a team.Excellent interpersonal, written and oral communication skills.Strong relevant subject matter knowledge.Ability to direct the work of others, for jobs requiring supervision.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates, Association of Clinical Research Professionals certification, or PMP is preferred. Regulatory Affairs Certificate, optional.

PHYSICAL REQUIREMENTS*:

Constantly perform desk-based computer tasks. Frequently stand/walk, sitting, grasp lightly/fine manipulation.Occasionally use a telephone. Rarely lift/carry/push/pull objects that weigh 11-20 pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORK STANDARDS:

Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.

The expected pay range for this position is $116,849 to $148,275 per annum.
Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website (https://cardinalatwork.stanford.edu/benefits-rewards) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources at stanfordelr@stanford.edu. For all other inquiries, please submit a contact form.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.