Clinical Research Manager

Desired Qualifications:

• Five years of clinical research experience in an academic health center, pharmaceutical, biotechnology, or CRO industry or equivalent.
• Three years of experience as a research manager or equivalent formal supervision duties.
• Clinical Research Certificate (ACRP, SOCRA, CROP).
• Ensures work is done on time in a high-quality manner.
• Knowledge of clinical pharmacology and pathophysiology, and food allergy research.
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities.
• Experience managing cross-functional teams or work groups as well as direct reports.
• Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials.
• Strong regulatory knowledge and ability to perform monitoring of CRFs, GCP and GMP. This position must know IRB regulations and how to perform IRB submissions. Working knowledge of FDA procedures as applicable, and ICH-GCP and relevant SOPs.
• Disciplined work approach with the ability to function independently, take initiative and effectively problems solve issues.
• Customer service oriented both internally and externally with strong organizational, interpersonal and communication skills.

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 Conditions:

• 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/.
• This position may have a flexible work location, with the possible ability to be either co-located near the Stanford campus or in Palo Alto, CA as a hybrid worker.