Clinical Research Manager

Note the following position will be based on the Stanford campus and is a hybrid (working on-site and working from home) subject to operational needs.

Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of the Emergency Medicine Clinical Research Unit. 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. The Clinical Research Manager will provide leadership and oversight of studies conducted in the Stanford Emergency Department, lead multiple clinical research staff meetings (group and individual). The Clinical Research Manager will also manage clinical research operations, relationships with ED clinical leadership and staff, study quality management, personnel management and career skill development, regulatory compliance, and fiscal oversight.

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.

* - Other duties may also be assigned

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related field and five years of direct clinical research experience, or an equivalent combination of education and relevant experience. Master's degree preferred.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Excellent interpersonal skills.
• Proficiency in Microsoft Office and database applications with particular strengths with Excel, Word and Powerpoint.
• 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

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.

Additional Information

• Schedule: Full-time
• Job Code: 4926
• Employee Status: Regular
• Grade: I
• Requisition ID: 91927