Clinical Research Coordinator 2

Stanford Reglab; California; On-site; USD 70,000 - 100,000; Full time

Job summary

Stanford Reglab is seeking a Clinical Research Coordinator to independently manage complex studies and oversee recruitment, data collection, and regulatory compliance. The role involves coordinating with investigators, sponsoring organizations, and regulatory bodies to ensure ethical conduct and timely study milestones.

You will mentor junior staff, develop schedules and budgets, audit procedures, and contribute to improving study processes.

Qualifications

• Bachelor’s degree in a related field with two years of clinical research experience, or an equivalent combination.
• Experience with clinical research protocols and regulatory bodies (HIPAA, FDA, IRB).
• Strong interpersonal skills and data management abilities.

Responsibilities

• Oversee subject recruitment and enrollment goals.
• Develop and manage systems to organize, collect, report, and monitor data.
• Develop project schedules, targets, measurements, and accountabilities; lead team meetings.
• Formally supervise, train, and mentor new staff or students.
• Audit operations to ensure regulatory compliance and oversee IRB submissions.
• Collaborate with principal investigators and study sponsors; monitor adverse events.
• Provide leadership in policy/process improvements and best practices.
• Develop study budgets and track milestones; invoice sponsors.
• Ensure regulatory compliance of study documents.
• Coordinate IND submissions and IRB renewals when applicable.

Skills

Interpersonal skills

MS Office proficiency

Regulatory knowledge

Medical terminology

Education

Bachelor’s degree + 2 years clinical research

Job description

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.

Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.

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.

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.