Clinical Research Manager

Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.

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.

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.

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver''s License.

• Ability to drive day or night.

• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

Core Duties:

• 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.

• May lead or chair committees or task forces to address and resolve significant issues resulting from research activities.

• 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 ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

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

Core Duties:

• 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.

• May lead or chair committees or task forces to address and resolve significant issues resulting from research activities.

• 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 ensure 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.

Minimum Education:

Bachelor's degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master''s degree preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy 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.

• Demonstrated disease knowledge / study design experience of studies under purview.

Certificates and Licenses Required

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