Clinical Research Coordinator III

Stanford University is seeking a Lead Clinical Research Coordinator to lead clinical research projects and contribute to progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. May include the supervision of clinical research staff.

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:

• May be exposed to blood borne pathogens.
• May be required to work non-standard, extended or weekend hours in support of research or project work.

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, .

Core Duties:

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.

• Monitor and oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.

• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.

• Supervision of staff or students, as assigned, including hiring, performance management and coaching; mentoring and training of staff and assistance with preparation of performance evaluations for staff who do not directly report to this role, and performing related duties, in addition to instruction on project work.

• Audit operations, including performing internal monitoring, 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. May have specialization such as leading training for the group, leading quality program for the group or other specialized and more complex responsibilities.

• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries. Analyze completed study results to aid PI in the development of recommendations to enhance quality outcomes.

• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.

• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Develop and manage the financial timeline and personnel resources; may oversee post-award deliverable.

• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.

• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

Minimum Education:

Bachelor's degree in a related field

Minimum Experience:

Four years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills and Abilities:

• 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 project/program leadership skills.

• 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.

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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.