Stanford Blood Center
Cancer Clinical Research Coordinator 2 - EDD (Hybrid)
Stanford Blood Center, Stanford, California, United States, 94305
Overview
Cancer Clinical Research Coordinator 2 – Early Drug Development (Hybrid Work Arrangement)
The Stanford Cancer Institute (SCI) is one of a select group of National Cancer Institute-Designated Comprehensive Cancer Centers and is part of the Stanford University School of Medicine. The SCI collaborates across schools and departments to advance cancer research, treatment, education and outreach. The Cancer Clinical Trials Office (CCTO) supports translating research into the clinical setting. You will work with an exceptional team of faculty and staff to contribute to transforming cancer care.
Reporting to the Early Drug Development Clinical Research Manager, the Cancer Clinical Research Coordinator 2 will align with the Institute’s goals and priorities, providing leadership within the clinical research team. The role requires excellent organizational skills, attention to detail, professionalism, initiative and flexibility. The CRC2 will independently manage significant aspects of a large study or all aspects of a few smaller studies, coordinating and managing clinical trials within the early drug development portfolio and collaborating with internal and external stakeholders to achieve trial objectives.
Responsibilities
Oversee and manage 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; extract and analyze data.
Develop project schedules, targets, measurements and accountabilities. Lead team meetings and prepare/approve minutes.
Mentor new staff or students as assigned, potentially including hiring, preparing/permitting performance evaluations, and related duties, in addition to instruction on project work.
Audit operations, including laboratory procedures, for regulatory compliance; lead 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 and implementing improvements to policies/processes and define best practices.
Develop study budgets with staff and principal investigator, distinguishing standard of care from study procedures. Track patient and study milestones and invoice sponsors accordingly.
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 and ensure Institutional Review Board renewals are completed.
Hybrid work arrangement.
* - 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 motor skills.
Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift/carry/push/pull up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift/carry/push/pull more than 40 pounds.
* 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 the job.
Working Conditions
Position may require work in areas with hazardous materials or exposure to chemicals, blood, body fluids, tissues and risks of contagion.
May require extended or unusual work hours based on research requirements and business needs.
Working Standards
Interpersonal Skills: Ability to work well with Stanford colleagues, clients and external organizations.
Promote Culture of Safety: Commitment to safety; communicate safety concerns; follow safe practices.
Compliance: Follow all applicable University policies and procedures.
The expected pay range for this position is $86,248 to $100,158 per annum.
Stanford University provides pay ranges as a good faith estimate of pay for a position. The final offer will consider scope, qualifications, budget, internal equity, location and market.
Stanford University offers extensive benefits; details will be discussed during the hiring process.
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 any other characteristic protected by law.
The job duties listed are typical examples and not a comprehensive inventory of all duties. Responsibilities may vary by department or program, and employees may perform other duties as assigned.
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The Stanford Cancer Institute (SCI) is one of a select group of National Cancer Institute-Designated Comprehensive Cancer Centers and is part of the Stanford University School of Medicine. The SCI collaborates across schools and departments to advance cancer research, treatment, education and outreach. The Cancer Clinical Trials Office (CCTO) supports translating research into the clinical setting. You will work with an exceptional team of faculty and staff to contribute to transforming cancer care.
Reporting to the Early Drug Development Clinical Research Manager, the Cancer Clinical Research Coordinator 2 will align with the Institute’s goals and priorities, providing leadership within the clinical research team. The role requires excellent organizational skills, attention to detail, professionalism, initiative and flexibility. The CRC2 will independently manage significant aspects of a large study or all aspects of a few smaller studies, coordinating and managing clinical trials within the early drug development portfolio and collaborating with internal and external stakeholders to achieve trial objectives.
Responsibilities
Oversee and manage 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; extract and analyze data.
Develop project schedules, targets, measurements and accountabilities. Lead team meetings and prepare/approve minutes.
Mentor new staff or students as assigned, potentially including hiring, preparing/permitting performance evaluations, and related duties, in addition to instruction on project work.
Audit operations, including laboratory procedures, for regulatory compliance; lead 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 and implementing improvements to policies/processes and define best practices.
Develop study budgets with staff and principal investigator, distinguishing standard of care from study procedures. Track patient and study milestones and invoice sponsors accordingly.
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 and ensure Institutional Review Board renewals are completed.
Hybrid work arrangement.
* - 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 motor skills.
Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift/carry/push/pull up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift/carry/push/pull more than 40 pounds.
* 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 the job.
Working Conditions
Position may require work in areas with hazardous materials or exposure to chemicals, blood, body fluids, tissues and risks of contagion.
May require extended or unusual work hours based on research requirements and business needs.
Working Standards
Interpersonal Skills: Ability to work well with Stanford colleagues, clients and external organizations.
Promote Culture of Safety: Commitment to safety; communicate safety concerns; follow safe practices.
Compliance: Follow all applicable University policies and procedures.
The expected pay range for this position is $86,248 to $100,158 per annum.
Stanford University provides pay ranges as a good faith estimate of pay for a position. The final offer will consider scope, qualifications, budget, internal equity, location and market.
Stanford University offers extensive benefits; details will be discussed during the hiring process.
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 any other characteristic protected by law.
The job duties listed are typical examples and not a comprehensive inventory of all duties. Responsibilities may vary by department or program, and employees may perform other duties as assigned.
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