"Clinical Research Coordinator 2"

This is a one (1) full-time (100% FTE), benefits-eligible, fixed term position for one (1) year. Although not guaranteed, there will be potential for an extension/renewal following the initial 1-year contingent upon additional funding commitments and/or programmatic needs.

Are you passionate about human performance and preventing common sports injuries? Do you thrive in dynamic environments where cutting-edge research and innovation intersect with operational excellence?

The Wu Tsai Human Performance Alliance at Stanford is seeking a highly organized and motivated Clinical Research Coordinator 2. This position requires a detail-oriented professional who can manage complex research projects and coordinate laboratory operations.

What is the Wu Tsai Human Performance Alliance?

The Wu Tsai Human Performance Alliance at Stanford is a university-wide research initiative, housed under the Vice Provost and Dean of Research (VPDoR), that leverages Stanford’s exceptional research, outstanding athletics, and innovative spirit. We are creating a community that draws on diverse efforts across campus to uncover the fundamental principles of peak performance. Through our programs, we are developing the knowledge, the people, and the tools to make optimal health more accessible to all. We hope you will join us in our mission and welcome candidates from all backgrounds to apply.

POSITION SUMMARY

We seek a Clinical Research Coordinator to support the Wu Tsai Human Performance Alliance’s Human Performance Lab and an ongoing, large-scale study to screen athletes for risk of anterior cruciate ligament injury. This role involves the execution, management, and coordination of research projects and laboratory operations with minimal supervision. The ideal candidate will execute responsibilities in a professional manner, ensuring seamless communication and project management within this dynamic and interdisciplinary environment. This role involves frequent travel to field sites and collecting data during extended periods outdoors.

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 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.
• Travel to research sites (e.g., high schools, colleges, community training facilities) to conduct participant data collection, including setup of study equipment, coordination with site staff, and documentation of procedures and data quality.

MINIMUM REQUIREMENTS

Education & 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 are essential, as you will be working closely with a large research team, athletes, minors, and their parents.
• 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.

Certifications and 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, if applicable.

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, if applicable.
• Able to walk, pull a wagon with camera and satellite equipment, assist with set up, and spend hours standing outdoors helping collect data from athletes. Applicants should be prepared for hands-on, active fieldwork as part of the research team.

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.

Onsite/Hybrid:

The expected pay range for this position is $86,248.00 to $100,158.00 per annum.