The Department of Medicine, Division of Cardiovascular Medicine is seeking a Clinical Research Manager (CRM) to provide leadership and oversight of multiple clinical research projects for faculty in the Interventional Cardiac Group. The mission of Cardiovascular Medicine is to conduct high-impact, innovative clinical research to improve human health. The CRM will shape and lead the exciting growth of a new clinical research team.

The successful applicant will have the ability to supervise multiple clinical research staff and enjoy working in a dynamic work environment.  Exceptional diplomacy, interpersonal and communication skills are essential, as is a high degree of integrity.

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.

*- 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.

DESIRED QUALIFICATIONS:

• Degree or certification in clinical research, public health or management.

EDUCATION & EXPERIENCE (REQUIRED):

• Bachelor’s degree in related field and five years of experience in clinical research, 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.
• 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 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, https://adminguide.stanford.edu/.

Why Stanford is for You:

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

*- 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.

Additional Information

• Schedule: Full-time
• Job Code: 4926
• Employee Status: Regular
• Grade: J
• Requisition ID: 87161