Clinical Research Coordinator

Stanford University School of Medicine; Palo Alto (CA); On-site; USD 55,000 - 85,000; Full time

Job summary

Stanford University School of Medicine’s Tass Lab in Neurological Surgery seeks a Clinical Research Coordinator to coordinate Parkinson’s disease studies, including device trials for neuromodulation and longitudinal natural history research. The role is on-site up to five days a week, with occasional evenings and weekends as needed.

You will oversee data management, recruitment, regulatory compliance, and budgets, collaborating with PIs and study sponsors to support industry, federal and

Qualifications

• Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Proficiency in Microsoft Office and database applications.
• Knowledge of HIPAA, FDA regulations, IRB requirements and Good Clinical Practices.

Responsibilities

• Oversee subject recruitment and study enrollment goals; determine strategies to promote/recruit and retain participants in long-term trials.
• Oversee data management: organize, collect, report, monitor data; extract, analyze, interpret data.
• Develop project schedules, targets, measurements and accountabilities; lead team meetings and prepare minutes.
• Supervise, train and mentor staff or students; assist with performance evaluations as needed.
• Audit operations for regulatory compliance; monitor IRB submissions and respond to queries.
• Collaborate with principal investigators and sponsors; monitor adverse events and resolution of study queries.
• Develop study budgets; track milestones and invoice sponsors per contract.
• Ensure regulatory compliance; inspect study documents and ensure ongoing compliance.

Skills

Interpersonal skills

Medical terminology

Regulatory knowledge

Clinical research protocols

Education

Bachelor's degree

2 years clinical research experience

Tools

Microsoft Office

Database applications

Job description

Job Description

The Tass Lab at Stanford University’s Department of Neurosurgery is seeking a Clinical Research Coordinator to perform duties related to the coordination of innovative clinical research studies focused on Parkinson’s disease. This key role offers a unique opportunity to partner directly with faculty to transform groundbreaking research visions into clinical reality. This position includes managing device trials for neuromodulation, conducting longitudinal natural history studies, and assisting with various PI-initiated projects involving adult subjects. As a Clinical Research Coordinator, you will oversee complex aspects of multiple studies under the close supervision of the Clinical Research Manager and the Principal Investigator. You will contribute to industry, federal, and grant-funded clinical research initiatives, providing a unique opportunity for long-term growth within the team while also serving as an excellent launching pad for a career in biomedical sciences. This full-time position requires the expectation of being on-site up to five days a week. Occasional evening and weekend hours may be necessary.

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.

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.
• 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.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• 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.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• 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.
• 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 And Experience

Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Knowledge, Skills And Abilities

• Strong 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.

Certificates And Licenses Required

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

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.