Clinical Research Coordinator 2 - HYBRID

Stanford Radiology is committed to providing exceptional patient care through technology, innovation, and compassion while educating and training the next generation of leaders in patient care and research. Our research programs span advanced technologies and clinical applications, including molecular imaging, medical imaging, image-guided therapeutics, medical devices, and informatics to advance precision health.

At Radiology, we are committed to recruiting team members who are enthusiastic about their work, adaptable, collaborative, and motivated to achieve meaningful outcomes. We provide our staff with the tools and opportunities needed to develop new skills, grow professionally, and advance within the organization. We also value and support a healthy work-life balance.

The Clinical Research Coordinator 2 (CRC2) will work closely with Principal Investigators, the Clinical Research Manager (CRM), research staff, clinical teams, sponsors, and institutional partners in a dynamic research environment. The CRC2 will independently coordinate multiple complex clinical research studies within the Department of Radiology, including investigator-initiated and industry-sponsored research. Studies may involve advanced imaging technologies, investigational drugs and medical devices, molecular imaging, and image-guided procedures.

The CRC2 will independently manage key aspects of clinical research studies from start-up through close-out, including participant recruitment and coordination, regulatory activities, study operations, data management, sponsor interactions, and study financial logistics. The CRC2 will also train and mentor research staff, monitor study progress and compliance, identify operational barriers, and work collaboratively with investigators and research leadership to implement solutions and improve research processes.

The successful candidate will have a strong background in clinical research, excellent organizational and communication skills, demonstrated ability to independently manage multiple complex and time-sensitive projects, strong attention to detail, and the ability to proactively identify and resolve operational challenges.
 

DESIRED QUALIFICATIONS:
Investigator Initiated clinical trial experience

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.

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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.