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Inside Higher Ed · 1 week ago

Clinical Research Coordinator 2 (Fixed-term 2 years)

Stanford, CA

Full-time

Onsite

Entry, Mid Level

$86K/yr - $100K/yr

2+ years exp

Stanford University’s School of Medicine is a leading institution committed to improving health through education, research, and health care. They are seeking a Clinical Research Coordinator 2 to manage clinical research projects focused on surgical and ICU patients, ensuring data integrity and compliance with regulations.

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Responsibilities

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

May require working extended or unusual hours based on research requirements and business needs. This may include weekends and early or late hours. These requirements may be known several days in advance and can be discussed

Other duties may also be assigned

Qualification

Clinical research experienceData managementRegulatory complianceMicrosoft Office proficiencyResearch protocols knowledgeMedical terminology knowledgeClinical Practices knowledgeCertification in clinical researchInterpersonal skills

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

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