The Stanford Center for Clinical Research (SCCR) is seeking a Clinical Research Coordinator 2 (CRC-2) to support multiple research studies throughout the School of Medicine and with collaborators across the University. The CRC-2 may work with multiple Principal Investigators in different therapeutic areas, depending on the studies available at a given time.  The CRC-2 will conduct clinical research and work independently on progressively more complex projects/assignments, as well as independently manage significant and key aspects of a large study or all aspects of one or more small research studies. 

SCCR provides infrastructure and support to Clinical Research Investigators and Staff throughout the Department of Medicine and School of Medicine and aims to promote high-quality, globally impactful clinical research. We are a large and growing team with an emphasis on quality, effective operations, and a supportive environment.  

The CRC-2 will work in a dynamic atmosphere, with the ability to multi-task in a high-energy environment. The role will be responsible for training a multidisciplinary clinical team of experts in protocol-driven activities in collaboration with assistant CRCs and other research staff. The CRC-2 will be responsible for operational logistics, study start-up and close-out activities including but not limited to recruitment, screening, enrollment, ensuring efficient participant visit flow, clinical research data collection and entry, ensuring compliance with federal, state, local, and sponsor regulations, and ensuring overall logistical progress on the project. 

The position will interface with faculty, inpatient and outpatient clinical teams, collaborators, and SCCR senior leadership to report project progress, deliver study metrics and trouble shoot barriers. Outstanding communication and organizational skills are critical elements of this role, as the CRC-2 will work on accruing trials while also simultaneously be responsible for starting up new trials in the pipeline. Familiarity and ease with smartphone and mobile health app technology, experience with or understanding of digital health as pertaining to clinical research, the ability to manage challenges proactively, a strong attention to detail and prior experience in coordinating interventional drug and/or device trials are required in a successful candidate. 

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

DESIRED QUALIFICATIONS:

• 3-4 years of clinical research coordination experience, interventional drug/device trial experience preferred
• Excellent communication skills and problem solving skills
• Strong organizational skills and attention to detail
• A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, and exercise sound judgement in setting priorities
• Must be familiar with smartphone and mobile health app technology
• Must have an understanding of the role of digital health in clinical research
• Bilingual preferred

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. 
• May require a valid California 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.

*- 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 disease 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 bases 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.

Additional Information

Schedule: Full-time
Job Code: 4923
Employee Status: Regular
Grade: H
Requisition ID: 83910