Inside Higher Ed
Clinical Research Coordinator II
Inside Higher Ed, Palo Alto, California, United States, 94306
Overview
Join to apply for the
Clinical Research Coordinator II
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Inside Higher Ed . The Department of Neurology at Stanford University seeks a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments, managing significant aspects of large studies or all aspects of one or more small research studies. Responsibilities
Oversee subject recruitment and study enrollment goals. Determine 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. Lead team meetings and prepare/approve minutes. Formally supervise, train, and mentor new staff or students as assigned, potentially including hiring, preparing or assisting with performance evaluations, and related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure regulatory compliance; 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. Lead 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 milestones and invoice sponsors according to contract. Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with the 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. 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, including 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 grasping. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects 40 pounds or more. Reasonable accommodation may be provided for applicants with disabilities to perform essential functions. Working Conditions
Position may require work in areas with hazardous materials or exposure to chemicals, blood, body fluids or tissues, and risk of exposure to contagious diseases. May require extended or unusual work hours based on research requirements and business needs. Work Standards
Interpersonal Skills: ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: commitment to safety; communicates safety concerns; follows safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures. Compensation & Benefits
The expected pay range for this position is $84,856 to $97,021 per annum. Stanford provides pay ranges as a good faith estimate; final pay is determined based on factors such as scope and responsibilities, qualifications, and market conditions. The rewards package details are available on the Cardinal at Work site and discussed during the hiring process. Additional Information
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other characteristics protected by law. The job duties listed are typical examples and may vary. Employees may perform other duties as assigned. Schedule: Full-time Job Code: 4923 Employee Status: Regular Grade: H Requisition ID: 106194 Work Arrangement: Hybrid Eligible Location: Stanford University, Redwood City, CA (as applicable)
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Join to apply for the
Clinical Research Coordinator II
role at
Inside Higher Ed . The Department of Neurology at Stanford University seeks a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments, managing significant aspects of large studies or all aspects of one or more small research studies. Responsibilities
Oversee subject recruitment and study enrollment goals. Determine 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. Lead team meetings and prepare/approve minutes. Formally supervise, train, and mentor new staff or students as assigned, potentially including hiring, preparing or assisting with performance evaluations, and related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure regulatory compliance; 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. Lead 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 milestones and invoice sponsors according to contract. Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with the 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. 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, including 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 grasping. Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects 40 pounds or more. Reasonable accommodation may be provided for applicants with disabilities to perform essential functions. Working Conditions
Position may require work in areas with hazardous materials or exposure to chemicals, blood, body fluids or tissues, and risk of exposure to contagious diseases. May require extended or unusual work hours based on research requirements and business needs. Work Standards
Interpersonal Skills: ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: commitment to safety; communicates safety concerns; follows safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures. Compensation & Benefits
The expected pay range for this position is $84,856 to $97,021 per annum. Stanford provides pay ranges as a good faith estimate; final pay is determined based on factors such as scope and responsibilities, qualifications, and market conditions. The rewards package details are available on the Cardinal at Work site and discussed during the hiring process. Additional Information
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or other characteristics protected by law. The job duties listed are typical examples and may vary. Employees may perform other duties as assigned. Schedule: Full-time Job Code: 4923 Employee Status: Regular Grade: H Requisition ID: 106194 Work Arrangement: Hybrid Eligible Location: Stanford University, Redwood City, CA (as applicable)
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