Clinical Research Coordinator II

Stanford University•Stanford, CA

5d•Onsite

About The Position

The Department of Neurology at 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. 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.

Requirements

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.

Nice To Haves

Prior certifications or experience preferred with administering various cognitive, neuropsychometric and functional assessments like MMSE, MoCA, RBANS, CDR, ADCS- ADL, ADAS-Cog ,Motor and non-motor evaluations and other assessments as per study requirements.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
May require a valid California Driver's License.

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.