The Department of Neurology at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects and assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.
Duties include:
• Oversee subject recruitment and study enrollment goals. • Determine effective strategies for promoting recruiting research participants and retaining participants in long-term clinical trials. • Oversee data management for research projects. • Develop and manage systems to organize collect report and monitor data collection. • Extract analyze and interpret data. • Develop project schedules targets measurements and accountabilities as assigned. • Lead team meetings and prepare and approve minutes. • Formally supervise train and/or mentor new staff or students as assigned, potentially including hiring, preparing, or assisting with the preparation of performance evaluations and performing related duties in addition to instruction on project work.
Audit operations including laboratory procedures to ensure compliance with applicable regulations, provide leadership in identifying and implementing corrective actions, and processes. Monitor Institutional Review Board submissions and respond to requests and questions.
Collaborate with principal investigators and study sponsors, monitor and report serious adverse events and resolve study queries. Provide leadership in determining recommending and implementing improvements to policies and processes, define best practices.
Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones and invoice sponsors according to study contract.
Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
Other duties may also be assigned.
DESIRED QUALIFICATIONS
Prior certifications or experience preferred with administering various cognitive neuropsychometric and functional assessments like MMSE, MoCA, RBANS, CDR, ADCS-ADL, ADAS-Cog, Motor and non-motor evaluations, and other assessments as per study requirements.
EDUCATION & EXPERIENCE REQUIREMENTS
Bachelors 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, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices • Knowledge of medical terminology
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 and 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, and 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 their 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 Universitys Administrative Guide: http://adminguide.stanford.edu.
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 Universitys Administrative Guide: http://adminguide.stanford.edu.
EXPECTED PAY RANGE
The expected pay range for this position is $86,248 to $100,158 per annum.
STANFORD UNIVERSITY BENEFITS AND REWARDS
Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. 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: http://cardinalatwork.stanford.edu/benefits-rewards provides detailed information on Stanfords 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 UNIVERSITY
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.
JOB DUTIES
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.