Stanford University (US)
Cancer Clinical Research Coordinator 2 - Breast Oncology (Hybrid)
Stanford University (US), Stanford, California, United States, 94305
Overview
The Stanford Cancer Institute (SCI) is one of a limited number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country. The SCI works to build synergies and collaborations across Stanford University to advance cancer research, treatment, education and outreach. We seek a Clinical Research Coordinator 2 to oversee complex clinical trials in Breast Oncology, contributing to the mission to reduce cancer mortality. The Cancer Clinical Trials Office (CCTO) supports the translation of research from the laboratory to the clinic. The role reports to the Breast CRG Clinical Research Manager and requires professionalism, initiative and flexibility, with the ability to manage multiple priorities in a fast-paced, team-oriented environment. Hybrid work arrangement. The ideal candidate will have strong people and time-management skills and a track record of handling challenging tasks with minimal supervision.
Responsibilities
Oversee subject recruitment and study enrollment goals. Develop and implement 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. Extract, analyze, and interpret data.
Develop project schedules, targets, measurements, and accountabilities. Lead team meetings and prepare/approve minutes.
Formally supervise, train, and/or mentor new staff or students, potentially including hiring, contributing to performance evaluations, and providing instruction on project work.
Audit operations, including laboratory procedures, to ensure regulatory compliance; lead in identifying and implementing corrective actions. 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 evaluating and implementing improvements to policies and processes; help define best practices.
Develop study budgets with staff and principal investigators; distinguish standard of care from study procedures. Track milestones and invoice sponsors according to contracts.
Ensure regulatory compliance. Regularly inspect study documents for ongoing regulatory compliance.
Work with principal investigators to ensure Investigational New Drug applications are submitted to the FDA when applicable and ensure IRB renewals are completed.
Desirable Qualifications
Oncology clinical trial coordination experience.
Investigator-initiated clinical trial coordination experience.
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 bodies, including HIPAA and FDA regulations, IRB 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, and lift/carry/push/pull up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort/file paperwork or parts, or lift/carry/push/pull more than 40 pounds.
Working Conditions
Position may require work in areas with hazardous materials, exposure to chemicals, blood, body fluids or tissues, and potential exposure to contagious diseases.
Extended or unusual work hours may be required based on research needs.
Work Standards
Interpersonal skills:Ability to work well with Stanford colleagues, clients, and external organizations.
Promote culture of safety: Commit to personal safety and encourage safe practices; report safety concerns.
Compliance: Follow all applicable university policies and procedures.
The expected pay range for this position is $86,248 to $100,158 per annum. Stanford provides pay ranges as a good faith estimate. The final offer will reflect factors such as scope, qualifications, department budget, and market conditions. Benefits information is available at Cardinal at Work. Reasonable accommodations are provided for applicants and employees with disabilities. Equal employment opportunity: Stanford is an equal opportunity 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. Specific duties may vary by department or program needs, and employees may perform other duties as assigned.
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The Stanford Cancer Institute (SCI) is one of a limited number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country. The SCI works to build synergies and collaborations across Stanford University to advance cancer research, treatment, education and outreach. We seek a Clinical Research Coordinator 2 to oversee complex clinical trials in Breast Oncology, contributing to the mission to reduce cancer mortality. The Cancer Clinical Trials Office (CCTO) supports the translation of research from the laboratory to the clinic. The role reports to the Breast CRG Clinical Research Manager and requires professionalism, initiative and flexibility, with the ability to manage multiple priorities in a fast-paced, team-oriented environment. Hybrid work arrangement. The ideal candidate will have strong people and time-management skills and a track record of handling challenging tasks with minimal supervision.
Responsibilities
Oversee subject recruitment and study enrollment goals. Develop and implement 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. Extract, analyze, and interpret data.
Develop project schedules, targets, measurements, and accountabilities. Lead team meetings and prepare/approve minutes.
Formally supervise, train, and/or mentor new staff or students, potentially including hiring, contributing to performance evaluations, and providing instruction on project work.
Audit operations, including laboratory procedures, to ensure regulatory compliance; lead in identifying and implementing corrective actions. 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 evaluating and implementing improvements to policies and processes; help define best practices.
Develop study budgets with staff and principal investigators; distinguish standard of care from study procedures. Track milestones and invoice sponsors according to contracts.
Ensure regulatory compliance. Regularly inspect study documents for ongoing regulatory compliance.
Work with principal investigators to ensure Investigational New Drug applications are submitted to the FDA when applicable and ensure IRB renewals are completed.
Desirable Qualifications
Oncology clinical trial coordination experience.
Investigator-initiated clinical trial coordination experience.
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 bodies, including HIPAA and FDA regulations, IRB 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, and lift/carry/push/pull up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort/file paperwork or parts, or lift/carry/push/pull more than 40 pounds.
Working Conditions
Position may require work in areas with hazardous materials, exposure to chemicals, blood, body fluids or tissues, and potential exposure to contagious diseases.
Extended or unusual work hours may be required based on research needs.
Work Standards
Interpersonal skills:Ability to work well with Stanford colleagues, clients, and external organizations.
Promote culture of safety: Commit to personal safety and encourage safe practices; report safety concerns.
Compliance: Follow all applicable university policies and procedures.
The expected pay range for this position is $86,248 to $100,158 per annum. Stanford provides pay ranges as a good faith estimate. The final offer will reflect factors such as scope, qualifications, department budget, and market conditions. Benefits information is available at Cardinal at Work. Reasonable accommodations are provided for applicants and employees with disabilities. Equal employment opportunity: Stanford is an equal opportunity 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. Specific duties may vary by department or program needs, and employees may perform other duties as assigned.
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