Clinical Research Coordinator Associate (24-Month Fixed-Term)

Clinical Research Coordinator Associate (24-Month Fixed-Term) Stanford, CA, United States (On-site) Job Description The Division of Child Neurology is seeking a Clinical Research Coordinator Associate (CRCA) to coordinate a variety of new and ongoing pediatric neurology clinical research projects. The Clinical Research Coordinator is responsible for the overall management and implementation of an assigned set of multiple research protocols, ensuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics. The candidate will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research. Key responsibilities include preparing initial study documents for IRB submission, advising on protocol amendments and renewals, recruiting, screening, assisting in the informed consent process, enrolling subjects in accordance with good clinical practice guidelines, collecting and recording data in compliance with HIPAA, participating in data retrieval and reporting, handling specimen collection and processing, maintaining drug accountability, ensuring subject compliance, reporting serious adverse events promptly to investigators, sponsors and the IRB, and protecting the rights, safety and well-being of human subjects. Duties Serve as primary contact with research participants, sponsors, and regulatory agencies, coordinating studies from startup through close‑out. Determine eligibility of and gather consent from study participants according to protocol and assist in developing recruitment strategies. Coordinate collection of study specimens and processing. Collect and manage patient and laboratory data for clinical research projects; develop flow sheets and other study documents, and complete case report forms. Ensure compliance with research protocols, audit case report forms for accuracy with source documents, and prepare regulatory submissions, ensuring IRB renewals are completed. Assemble study kits for visits, monitor scheduling and charges, coordinate documents, and attend monitoring meetings with sponsors. Monitor expenditures and adherence to study budgets, resolving billing issues in collaboration with finance and/or management staff. Interact regularly with the principal investigator, ensuring patient safety and adherence to proper study conduct. Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. Participate in monitoring visits and regulatory audits. Other duties may be assigned. Qualifications EDUCATION & EXPERIENCE (REQUIRED): Two‑year college degree and two years related work experience or a bachelor’s 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, light/fine grasping. Occasionally sit, reach above shoulders, perform desk‑based computer tasks, use a telephone, write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, and rarely lift, carry, push, and pull objects that weigh 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: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for 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. Benefits that support you, and your future 18+ PTO days per year Health benefits start when you start Flexible work options $6000+ annual tuition and training assistance 403(b) plan Mental health and wellness programs Free and discounted commuter transportation Applies to regular full‑time positions. Equal Employment Opportunity 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 Stanford University