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:

• Significant prior research and management experience, preferably in an engineering or cardiovascular-related field. The ability to think critically and carry out experiments independently is required.
• Background in mechanical engineering, biomedical engineering, bioengineering, computer science or related quantitative and or health field.
• Strong engineering fundamentals in fluid and solid / continuum mechanics, numerical methods, and/ or computational science, preferably with a PhD in engineering or related field.
• Solid software engineering skills including as programming in Python and / or Matlab.
• Experience with CAD software and/or 3D modeling software.
• Familiarity with image analysis (3D Slicer, Mimics) or medical imaging (optional).
• Experience running engineering simulations and performing associated analysis of simulation results. This includes finite element methods or computational fluid dynamics (Simvascular). Confidence with troubleshooting simulation results to ensure high quality outputs is needed.
• If coming from an engineering-oriented background, basic knowledge of anatomy/physiology are recommended.
• Advanced writing and reading ability, which could be demonstrated via prior publications.
• Knowledge of cardiovascular/cardiopulmonary anatomy & physiology. Developmental biology knowledge may also be beneficial as our work focuses on congenital heart diseases.
• Prior experience leading a team and project management working in a multidisciplinary environment, including excellent communication skills.
• Ability to independently develop efficient workflows for performing computational modeling and simulation in a fast-paced clinical setting.
• Excellent attention to detail and ability to implement quality assurance protocols for image segmentation and simulation results.

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):

• Strong interpersonal skills.
• Proficiency with Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Demonstrated managerial experience.
• Demonstrated knowledge and skills of advanced scientific or engineering principles and practices.
• Extensive experience applying complex scientific and engineering principles and performing special technical services and the ability to articulate and translate implementation requirements to the planning, design, development, operations, and performance of complex equipment and systems.
• Demonstrated ability to oversee, maintain, and develop a laboratory space including demonstrated ability to and supervise the work of technicians and other staff associated with the group.
• Demonstrated ability to critically review research proposals, evaluate research capabilities, and make recommendations.
• Demonstrated ability to establish, communicate, and enforce compliance with health and safety policies and procedures.
• Demonstrated ability to effectively supervise and train a diverse work staff.
• Demonstrated ability to contribute to health care policy formulation when working in partnership with a multidisciplinary team of health care providers.
• Demonstrated ability to delegate responsibly to others, activities according to ability, level of preparation, the standards of practice and regulatory guidelines.
• Demonstrated ability to develop programs and lead process improvement projects.
• Demonstrated ability to establish the strategic direction and business plans for a functional group.
• Demonstrated ability to initiate and implement change conducive to the improvement of the quality and safety of patient care delivery.
• Demonstrated ability to supervise, coach, mentor, train, and evaluate work results.
• Demonstrated ability to communicate effectively, both orally and in writing.
• Demonstrated ability to establish and maintain effective relationships with widely diverse groups, including individuals at all levels both within and outside the organization and gain their cooperation.
• Demonstrated ability to plan, organize, prioritize, work independently and meet deadlines.

CERTIFICATIONS & LICENSES:

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

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - 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.

WORKING CONDITIONS:

• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

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, .

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.