Clinical Research Coordinator 2 – Surgical Planning

Stanford University is seeking a Clinical Research Coordinator 2 as part of the new Surgical Planning Clinical service, to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. Perform advanced technical research utilizing and / or developing complex experimental equipment, devices, specimens, plans, designs, reports, and / or data analysis. Contributes to or may have responsibility for the planning, design and implementation of complex multiple disciplinary projects and the overall clinical service. Provides supervision and instruction to technicians, and / or support staff.

Duties include

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
• Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
• Determine effective strategies for promoting / recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
• Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions / processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
• Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
• Lead or chair committees or task forces to address and resolve significant issues.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
• Assist with analysis of data and preparation of manuscripts and scientific presentations.
• Support complex scientific and research programs; analyze data, monitor and oversee experimental process, and design and develop prototypes, specialized equipment, and / or systems.
• Collaborate with scientists, engineers, surgeons, clinicians or senior administrative officers to oversee complex non-routine analyses, select optimum solutions, design and develop special purpose equipment and / or systems, and perform corrective modifications to equipment and system designs.
• Contribute to or may have lead responsibility for the planning, design, and implementation of scientific, clinical or engineering initiatives, and work toward project objective.
• Oversee and make decisions independently for operation, maintenance, and development of laboratory space and clinical program.
• Oversee and prepare periodic financial and technical reports and operating plans. Lead all negotiations with billing and insurance with regards to program activities reimbursement.
• Establish, communicate, and enforce compliance with health and safety policies and procedures.
• Oversee development of training manuals and safety guidelines, and train new instrumentation users, researchers, and / or technical staff.
• Other duties may also be assigned.

DESIRED QUALIFICATIONS :

Disclaimer : A strong candidate does not need to possess ALL of the following qualifications, but should have at least some of these skills :

EDUCATION & EXPERIENCE (REQUIRED) :

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED) :

CERTIFICATIONS & LICENSES :

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS

WORKING CONDITIONS :

WORK STANDARDS :

The expected pay range for this position is $86,248 to $100,158 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 ( ) 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.

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 by submitting 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.

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.