The Research Management Group (RMG) serves as the central resource and expert partner on research administration providing support and oversight of sponsored projects for the School of Medicine at Stanford University. Within RMG, the Clinical Trials team oversees the administrative activities related to clinical trial and clinical study startup – budget development, contract negotiation and compliance review. We are seeking a Clinical Study Startup Program Lead who is passionate about clinical research and project management.
This position is a new role evolving from the School of Medicine's ROVER (Research Operations Vision, Excellence and Roadmap) initiative to improve and streamline research administration, including clinical study activation, across Stanford Medicine. The Clinical Study Startup Program Lead will define and continuously refine a standard project management approach within the School of Medicine for the startup of clinical studies from initial feasibility to study activation. The position will evolve over time to accommodate changes implemented through the School's process improvement initiatives.
Collaborating with Principal investigators, Research Management Group's clinical research administration team, study team participants and other department clinical research staff, the Clinical Study Startup Program Lead will leverage their knowledge of clinical research administration and operations, project management, and technical skills to codify standard work and roles, consolidate and refine existing tools and process guidance needed to ensure the timely and efficient start-up of clinical studies.
Duties include:
Establish a standard start up schedule with milestones and target intervals for clinical research start-up. Identify and establish tools and technology to track start up status.
Partner with clinical research stakeholders across the School of Medicine research enterprise to identify barriers in the project management process to efficient clinical research study startup. Develop refinements and solutions.
Identify and recommend new tools and processes to accelerate project start up.
Collaborate with faculty/PIs, clinical research staff in departments, and hospital and University staff to prototype and pilot the integration of systems and process alignment.
Track a portfolio of studies piloting strategies to attain sustainability for efficient clinical study startup within the SoM.
Support SoM and RMG training teams in the development and rollout of training content, materials and programs, including those related to the tools and technology used to facilitate and track the startup of clinical studies.
* - Other duties may also be assigned
DESIRED QUALIFICATIONS:
Knowledge of and experience with clinical research startup process, including research administration compliance considerations.
Experience with project management processes and systems and leading large projects with multiple stakeholders.
Ability to create and implement standard process documentation and tools (checklists, workflow diagrams, project management software).
Familiarity with OnCore or similar clinical trial management system.
Familiarity with Stanford research administration systems.
Comfortable with ambiguity, working in an evolving environment and supporting and facilitating change.
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.
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.
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.
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. Link
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.
The expected pay range for this position is $75,000 to $114,000 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.
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