Stanford University
Cancer Clinical Research Coordinator 2 – Breast Oncology (Hybrid)
Stanford University, Palo Alto, California, United States, 94306
Overview
Cancer Clinical Research Coordinator 2 - Breast Oncology (Hybrid) The Stanford Cancer Institute (SCI) is one of a select group of National Cancer Institute-Designated Comprehensive Cancer Centers in the country. The SCI collaborates with faculty across Stanford University to support cancer research, treatment, education and outreach. The Cancer Clinical Trials Office (CCTO) enables translation of research from the laboratory to the clinical setting. You will work with a team of faculty and staff in a fast-paced environment that values growth and professional development. The Clinical Research Coordinator 2 will be conversant in the Institute’s goals and priorities and oversee complex clinical research trials, with a focus on oncology and breast cancer trials. The position reports to the Breast CRG Clinical Research Manager and requires strong people and time management skills and a track record of handling challenges professionally and flexibly. Responsibilities include trial oversight and ensuring accrual targets are met. 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; extract, analyze, and interpret data. Develop project schedules, targets, measurements and accountabilities; lead team meetings and prepare/approve minutes. Supervise, train, and/or mentor new staff or students; may include hiring, preparing or assisting with performance evaluations, and instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with regulations; lead the identification and implementation of corrective actions; monitor Institutional Review Board submissions and respond to requests. 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 and processes; define best practices. Develop study budgets with staff and principal investigator; distinguish standard of care versus study procedures; track milestones and bill sponsors according to contract. Ensure regulatory compliance; inspect study documents to maintain ongoing regulatory compliance. Work with the principal investigator to submit Investigational New Drug applications to the FDA when applicable and ensure Institutional Review Board renewals are completed. Hybrid work arrangement. DESIRED 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 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, and pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, or lift and carry objects heavier than 40 pounds. Reasonable accommodations will be provided to employees with disabilities to perform essential job functions. WORKING CONDITIONS
Work may occur in areas with hazardous materials and exposures to chemicals, blood, body fluids or tissues, and risk of 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 and external organizations. Promote Culture of Safety: Demonstrate personal responsibility for safety; communicate safety concerns and 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 provides a pay range as a good faith estimate of compensation. Specific pay is determined based on factors such as the scope of the position, candidate qualifications, department budget, internal equity, geography and market data. The Cardinal at Work website provides details about benefits and rewards. 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 may vary; other duties may be assigned.
#J-18808-Ljbffr
Cancer Clinical Research Coordinator 2 - Breast Oncology (Hybrid) The Stanford Cancer Institute (SCI) is one of a select group of National Cancer Institute-Designated Comprehensive Cancer Centers in the country. The SCI collaborates with faculty across Stanford University to support cancer research, treatment, education and outreach. The Cancer Clinical Trials Office (CCTO) enables translation of research from the laboratory to the clinical setting. You will work with a team of faculty and staff in a fast-paced environment that values growth and professional development. The Clinical Research Coordinator 2 will be conversant in the Institute’s goals and priorities and oversee complex clinical research trials, with a focus on oncology and breast cancer trials. The position reports to the Breast CRG Clinical Research Manager and requires strong people and time management skills and a track record of handling challenges professionally and flexibly. Responsibilities include trial oversight and ensuring accrual targets are met. 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; extract, analyze, and interpret data. Develop project schedules, targets, measurements and accountabilities; lead team meetings and prepare/approve minutes. Supervise, train, and/or mentor new staff or students; may include hiring, preparing or assisting with performance evaluations, and instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with regulations; lead the identification and implementation of corrective actions; monitor Institutional Review Board submissions and respond to requests. 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 and processes; define best practices. Develop study budgets with staff and principal investigator; distinguish standard of care versus study procedures; track milestones and bill sponsors according to contract. Ensure regulatory compliance; inspect study documents to maintain ongoing regulatory compliance. Work with the principal investigator to submit Investigational New Drug applications to the FDA when applicable and ensure Institutional Review Board renewals are completed. Hybrid work arrangement. DESIRED 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 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, and pull objects up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, or lift and carry objects heavier than 40 pounds. Reasonable accommodations will be provided to employees with disabilities to perform essential job functions. WORKING CONDITIONS
Work may occur in areas with hazardous materials and exposures to chemicals, blood, body fluids or tissues, and risk of 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 and external organizations. Promote Culture of Safety: Demonstrate personal responsibility for safety; communicate safety concerns and 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 provides a pay range as a good faith estimate of compensation. Specific pay is determined based on factors such as the scope of the position, candidate qualifications, department budget, internal equity, geography and market data. The Cardinal at Work website provides details about benefits and rewards. 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 may vary; other duties may be assigned.
#J-18808-Ljbffr