Clinical Research Coordinator 2

Stanford University School of Medicine; Redwood City (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

Stanford University School of Medicine in California seeks a Clinical Research Coordinator 2 to support an active research portfolio across orthopaedic spine studies, industry-funded trials, registries, and grant projects. The CRC2 will act as the primary contact for sponsors, collaborators, IRBs, and internal stakeholders, coordinating with faculty, residents, fellows, and students.

This role offers meaningful responsibility in an academic medical center environment, focusing on data integrity,

Qualifications

• Bachelor's degree in a related field and two years of experience in clinical research or equivalent.
• Experience with HIPAA, FDA regulations, IRB requirements, and Good Clinical Practices.
• Strong interpersonal and communication skills.
• Proficiency in Microsoft Office and database applications.

Responsibilities

• Oversee subject recruitment and study enrollment goals.
• Oversee data management: organize, collect, report, monitor data; extract/analyze data.
• Develop project schedules, lead meetings, prepare minutes; supervise staff and students.
• Audit operations for regulatory compliance; monitor IRB submissions and responses.
• Collaborate with investigators and sponsors; monitor adverse events and resolve queries.
• Develop study budgets and track milestones; invoice sponsors per contract.
• Ensure regulatory compliance and submit INDs/IRB renewals when applicable.

Skills

Interpersonal skills

Microsoft Office

Regulatory knowledge

Medical terminology

Education

Bachelor's degree in a related field

Tools

Database applications

Microsoft Office Suite

Job description

Job Description
Stanford University's Department of Orthopaedic Surgery, Spine Division is seeking a highly motivated and experienced Clinical Research Coordinator 2 (CRC2) to support the research program. This position plays a central and independent role in managing all aspects of PI's research portfolio, including industry-funded clinical trials, multi-site collaborations, registry studies, and grant-funded projects including PI-Initiated projects. The CRC2 serves as the primary research contact for sponsors, collaborators, IRBs, and internal stakeholders, and will work closely with surgical faculty, residents, fellows, and students.

This is an excellent opportunity for an experienced research professional seeking meaningful responsibility in a dynamic academic medical center environment.

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

PHYSICAL REQUIREMENTS*:

• Ability to drive day or night.
• 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

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

Responsibilities

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.