Clinical Research Coordinator 2

Stanford University School of Medicine; Palo Alto (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Stanford University School of Medicine seeks a Clinical Research Coordinator 2 to conduct clinical research and manage progressively complex projects independently. You will oversee subject recruitment, enrollment goals, data management, and regulatory compliance, collaborating with investigators and study sponsors.

A Bachelor’s degree and at least two years of clinical research experience are required. Strong communication, problem-solving, and organizational skills are essential for success in

Qualifications

• Bachelor's degree in a related field and at least two years of clinical research experience.
• Experience with study protocols, regulatory requirements (HIPAA, FDA), and IRB processes.
• Strong interpersonal skills and proficiency with Microsoft Office and database tools.

Responsibilities

• Oversee subject recruitment and study enrollment goals.
• Oversee data management for research projects; develop systems to collect, report, and monitor data.
• Develop project schedules, targets, measurements, and accountabilities; lead team meetings.
• Formally supervise, train, and mentor new staff; assist with evaluations.
• Audit operations to ensure regulatory compliance; monitor IRB submissions and actions.
• Collaborate with principal investigators and sponsors; monitor adverse events and study queries.
• Provide leadership to improve policies and procedures; define best practices.
• Develop study budgets with staff and PI; track milestones and bill sponsors.
• Ensure regulatory compliance and prepare/submit necessary approvals.

Skills

Interpersonal skills

Microsoft Office

Database applications

Regulatory knowledge

Education

Bachelor's degree in related field

Job description

Job Description

Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

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 .

Responsibilities

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.

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.