"Clinical Research Coordinator 2 (CRC2)"

The Department of Orthopaedic Surgery is currently seeking a Clinical Research Coordinator 2 (CRC2). This role involves conducting and managing clinical research studies within Trauma Services, which specializes in orthopaedic trauma surgery. Our focus includes treating fractures of the upper extremity (excluding the hand), lower extremity, and pelvis, as well as addressing nonunions and malunions. Our team of orthopaedic trauma surgeons is dedicated to patient care and excellence in fellowship education and research.

Being recognized as an AO Trauma North America fellowship site for 2024-2025 is a significant achievement that underscores our commitment to high-quality training and education in trauma care. This position involves independently assigning trial workloads and managing performance through coaching and supervision of Clinical Research Coordinator Associates, medical students, medical scholars, residents, fellows, and post-docs. The CRC2 for Trauma reports to the Chief of Orthopaedic Trauma and serves as the resourcing lead and supervisor, ensuring project needs are met and adequate coverage is provided for workload trials.

The ideal candidate for this role is detail-oriented and conscientious, with excellent written and oral communication and interpersonal skills. To learn more about the department, please visit us at: https://ortho.stanford.edu

Duties include:

• 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 document 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.

* - Other duties may also be assigned.

EDUCATION & EXPERIENCE (REQUIRED):

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 (REQUIRED):

• Strong interpersonal skills.
• Proficiency with 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.

CERTIFICATIONS & LICENSES:

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
• Must possess and maintain a valid California non-commercial Class C Driver’s License.

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.
• Ability to drive day or night.

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.