"Clinical Research Coordinator 2"

The Stanford Stroke Center in Stanford University’s School of Medicine is seeking a Clinical Research Coordinator 2 (CRC2) to provide leadership and oversight, and to independently manage significant and key aspects of multiple complex clinical research projects.

The Stanford Stroke Center is a highly productive stroke and neurocritical care research center consisting of 16 faculty members and 8-10 research coordinators. The Stroke Center currently conducts multiple clinical trials in the acute, sub-acute and outpatient settings, encompassing acute intervention, diagnosis, observational, prevention and recovery trials. The CRC2 will report to the Program Manager and work closely with the Stroke and Neurocritical Care faculty/physician leaders. The selected candidate must have the ability to implement, organize and conduct all aspects of clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments).

S/he will support patients participating in research studies and medical faculty in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research experience is required. Previous clinical trial experience at Stanford and/or LPCH is highly desirable. The CRC2 will be responsible for the implementation of assigned clinical trials, and will participate in the shared research coordinator call schedule. S/he will also provide coverage for other members of the research team, and attend relevant departmental meetings.

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:

Previous clinical trial experience at Stanford and/or LPCH is highly desirable.

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.

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.

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.

The expected pay range for this position is $86,248 to $100,158 per annum.

Stanford University provides pay ranges representing its good faith estimate of the salary or hourly wage the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.