Stanford Blood Center
Cancer Clinical Research Coordinator Associate Breast Oncology (Hybrid)
Stanford Blood Center, Palo Alto, California, United States, 94306
Overview
Cancer Clinical Research Coordinator Associate (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) is an elite National Cancer Institute-Designated Comprehensive Cancer Center within the Stanford University School of Medicine. The SCI collaborates across Schools and departments to advance cancer research, treatment, education and outreach. The Clinical Trials Office (CTO) is an integral component that enables translation of research from the laboratory to the clinical setting. You will work with faculty and staff who are advancing cancer care. Reporting to the Cancer Clinical Research Manager for Breast Oncology, the Cancer Clinical Research Coordinator Associate will manage data, enroll and follow patients on trials, and assist with regulatory and financial requirements of the trials. The role requires excellent written and verbal communication, reliability in delivering assigned deliverables, and a history of handling challenges professionally with initiative and flexibility. Responsibilities include data management, enrolling and following patients on trials. Core duties
Serve as the primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and obtain consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research databases, develop flow sheets and study documents, and complete case report forms. Ensure compliance with research protocols, review and audit case report forms for accuracy with source documents. Prepare regulatory submissions and ensure IRB renewals are completed. Assemble study kits for visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets; resolve billing issues with finance or management staff. Interact with the principal investigator regularly to ensure patient safety and proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. Hybrid work agreement. Other duties may also be assigned. DESIRED QUALIFICATIONS
Knowledge of the principles of clinical research and federal regulations. Familiarity with IRB guidelines and regulations. Previous experience with clinical trials. Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. EDUCATION & EXPERIENCE (REQUIRED)
Two year college degree and two years related work experience or a Bachelors degree in a related field or an equivalent combination of related education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED)
Strong interpersonal skills. Proficiency with Microsoft Office. 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 40 pounds or more. * 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
Occasional evening and weekend hours. WORK STANDARDS
Interpersonal Skills: Ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Commitment to personal responsibility and safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures. The expected pay range for this position is $34.56 to $40.30 per hour. Stanford University provides pay ranges as a good faith estimate of compensation. The base pay is complemented by a comprehensive rewards package; specifics may be discussed during the hiring process. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
Cancer Clinical Research Coordinator Associate (Hybrid Work Schedule) The Stanford Cancer Institute (SCI) is an elite National Cancer Institute-Designated Comprehensive Cancer Center within the Stanford University School of Medicine. The SCI collaborates across Schools and departments to advance cancer research, treatment, education and outreach. The Clinical Trials Office (CTO) is an integral component that enables translation of research from the laboratory to the clinical setting. You will work with faculty and staff who are advancing cancer care. Reporting to the Cancer Clinical Research Manager for Breast Oncology, the Cancer Clinical Research Coordinator Associate will manage data, enroll and follow patients on trials, and assist with regulatory and financial requirements of the trials. The role requires excellent written and verbal communication, reliability in delivering assigned deliverables, and a history of handling challenges professionally with initiative and flexibility. Responsibilities include data management, enrolling and following patients on trials. Core duties
Serve as the primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out. Determine eligibility of and obtain consent from study participants according to protocol. Assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects. Manage research databases, develop flow sheets and study documents, and complete case report forms. Ensure compliance with research protocols, review and audit case report forms for accuracy with source documents. Prepare regulatory submissions and ensure IRB renewals are completed. Assemble study kits for visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Monitor expenditures and adherence to study budgets; resolve billing issues with finance or management staff. Interact with the principal investigator regularly to ensure patient safety and proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitor visits and regulatory audits. Hybrid work agreement. Other duties may also be assigned. DESIRED QUALIFICATIONS
Knowledge of the principles of clinical research and federal regulations. Familiarity with IRB guidelines and regulations. Previous experience with clinical trials. Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. EDUCATION & EXPERIENCE (REQUIRED)
Two year college degree and two years related work experience or a Bachelors degree in a related field or an equivalent combination of related education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED)
Strong interpersonal skills. Proficiency with Microsoft Office. 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 40 pounds or more. * 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
Occasional evening and weekend hours. WORK STANDARDS
Interpersonal Skills: Ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Commitment to personal responsibility and safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures. The expected pay range for this position is $34.56 to $40.30 per hour. Stanford University provides pay ranges as a good faith estimate of compensation. The base pay is complemented by a comprehensive rewards package; specifics may be discussed during the hiring process. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr