Inside Higher Ed
Cancer Clinical Research Coordinator 2 - CCT/BMT(Hybrid)
Inside Higher Ed, Palo Alto, California, United States, 94306
Overview
Cancer Clinical Research Coordinator 2 - CCT/BMT(Hybrid) at Stanford University School of Medicine. The Cancer Institute seeks a Clinical Research Coordinator 2 to help enact its mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. The position reports to the Clinical Research Manager of Blood and Marrow Transplantation and Cell Therapy (BMT-CT) and operates in a fast-paced, team-oriented environment with opportunities for professional growth. Hybrid work arrangement. Responsibilities
Oversee subject recruitment and study enrollment goals. Develop 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, including hiring support, preparing performance evaluations, and instructing on project work. Audit operations, including laboratory procedures, to ensure regulatory compliance; 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 policy/process improvements and define best practices. Develop study budgets with staff and principal investigator; distinguish standard of care from study procedures; track milestones and invoice sponsors per contract. Ensure regulatory compliance and ongoing review of study documents; assist with Investigational New Drug applications to the FDA when applicable and ensure IRB renewals are completed. Work in a Hybrid work arrangement and perform other duties as assigned. Qualifications
Education & Experience (required): Bachelors degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. Experience with oncology clinical research studies; experience in Blood and Marrow Transplant or cellular therapy preferred. Minimum of two (2) years of experience in a clinical research setting. Knowledge, Skills and Abilities (required): Strong interpersonal skills; proficiency with Microsoft Office and database applications; experience with research protocols and regulatory bodies (HIPAA, FDA, IRB, Good Clinical Practices); knowledge of medical terminology. Certifications & Licenses: Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred. Physical Requirements
Frequent standing, walking, bending; ability to perform desk-based computer tasks; lift up to 40 pounds as needed. Reasonable accommodation will be provided as required by law. Working Conditions
May involve exposure to hazardous materials, blood, body fluids or tissues; risk of exposure to contagious diseases. May require extended or unusual work hours based on research requirements. Other
Schedule: Full-time Job Code: 4923 Work Arrangement: Hybrid Eligible Requisition ID: 107216
#J-18808-Ljbffr
Cancer Clinical Research Coordinator 2 - CCT/BMT(Hybrid) at Stanford University School of Medicine. The Cancer Institute seeks a Clinical Research Coordinator 2 to help enact its mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. The position reports to the Clinical Research Manager of Blood and Marrow Transplantation and Cell Therapy (BMT-CT) and operates in a fast-paced, team-oriented environment with opportunities for professional growth. Hybrid work arrangement. Responsibilities
Oversee subject recruitment and study enrollment goals. Develop 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, including hiring support, preparing performance evaluations, and instructing on project work. Audit operations, including laboratory procedures, to ensure regulatory compliance; 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 policy/process improvements and define best practices. Develop study budgets with staff and principal investigator; distinguish standard of care from study procedures; track milestones and invoice sponsors per contract. Ensure regulatory compliance and ongoing review of study documents; assist with Investigational New Drug applications to the FDA when applicable and ensure IRB renewals are completed. Work in a Hybrid work arrangement and perform other duties as assigned. Qualifications
Education & Experience (required): Bachelors degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience. Experience with oncology clinical research studies; experience in Blood and Marrow Transplant or cellular therapy preferred. Minimum of two (2) years of experience in a clinical research setting. Knowledge, Skills and Abilities (required): Strong interpersonal skills; proficiency with Microsoft Office and database applications; experience with research protocols and regulatory bodies (HIPAA, FDA, IRB, Good Clinical Practices); knowledge of medical terminology. Certifications & Licenses: Society of Clinical Research Associates or Association of Clinical Research Professionals certification preferred. Physical Requirements
Frequent standing, walking, bending; ability to perform desk-based computer tasks; lift up to 40 pounds as needed. Reasonable accommodation will be provided as required by law. Working Conditions
May involve exposure to hazardous materials, blood, body fluids or tissues; risk of exposure to contagious diseases. May require extended or unusual work hours based on research requirements. Other
Schedule: Full-time Job Code: 4923 Work Arrangement: Hybrid Eligible Requisition ID: 107216
#J-18808-Ljbffr