Clinical Research Coordinator 2
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Stanford, CALIFORNIA, us
Posted Dec 11, 2023
- Full-time
- Other
Job description
At the Sean N. Parker Center for Allergy and Asthma Research, the world's leading scientists, physician-scientists, and research teams come together to study and understand the molecular underpinnings of allergies and asthma. We are committed to finding causes, treatments, and cures for allergies and asthma, and bringing these to children, adults, and their families at local and global levels. Transforming lives with innovative science and compassionate care. Duties include: 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 collection. Extract, analyze, and interpret data. Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. 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 determining, recommending, and implementing improvements to policies/processes; define best practices. Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract. Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Prior experience in a clinical research setting Bachelors degree in a related field 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 in Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include 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. May require a valid California Driver’s License. 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 and 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, 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 his or her job. WORKING CONDITIONS: Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs. WORKING 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, including but not limited to the personnel policies and other policies found in the University’s Administrative Guide,