Clinical Research Manager Jobs

Research

Clinical Research Manager

Grade J Job Code 4926 Employee Status Regular Schedule Full-time Requisition ID 99004

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We are seeking a Clinical Research Manager (CRM) who is passionate about clinical research and project management. The CRM will report to the Director of Clinical Research and work with a robust clinical research team, hand in hand with Principal Investigators, Clinical Research Managers, Nurse Managers, and Associates in support of cardiac patients. The Clinical Research Manager will provide leadership and oversight of studies conducted by several affinity groups within the Division, including General Cardiology and the Preventive Cardiology group. The Clinical Research Manager will manage clinical research operations, relationships with other affinity groups and staff, study quality management, personnel management and career skill development, regulatory compliance and fiscal oversight. The CRM will also assist with building automated clinical research workflows and solutions within the Division.

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

CV Med Clinical Research is a growing, dynamic team who are dedicated to supporting translational medicine and contributing to Stanford Medicine’s mission. We invite you to join our team!

Duties Include

• 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.
• 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.
• Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
• 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.
• Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
• 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.
• 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.
• 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.

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

• Experience developing reports and dashboards
• Experience with Smartsheet

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.
• Demonstrated managerial experience.
• 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.

Certifications & Licenses

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

Physical Requirements

• 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.
• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• 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.

Working Standards

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• 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,
• 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.

The expected pay range for this position is $107,000 to $131,000 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.

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

• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• 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.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• 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.
• 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.

School of Medicine employees who are patient-facing, work in, or frequent clinical and hospital areas for work purposes are considered as healthcare workers. This position is considered a healthcare worker and will need to comply with the Stanford Medicine vaccination requirements including the primary series of COVID 19 vaccines.