Join to apply for the Clinical Research Coordinator Associate role at Stanford University School of Medicine Join to apply for the Clinical Research Coordinator Associate role at Stanford University School of Medicine Stanford Universitys Department of Dermatology is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the principal investigator and/or manager/supervisor. The CRCA will support federal and non-federal clinical research studies including dermatological and investigative work in support of clinical trials, clinical research or biomedical research focusing on bench to bedside treatment. Duties Include Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Determine eligibility of and gather 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 project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed. Assemble study kits for study 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 and resolve billing issues in collaboration with finance and/or management staff. Interact with the principal investigator regularly, 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 monitor visits and regulatory audits. - Other duties may also be assigned Desired Qualifications A Bachelors degree with an educational background in medicine and/or scientific field (biological sciences, social sciences, etc.) Three years of clinical research experience preferred. Clinical research project management experience. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Proven ability to work independently and take ownership of a project. Proven ability to work collaboratively and cooperatively in a team environment. Ability to work effectively in a fast-paced environment with multiple projects and timelines. Strong oral and written communication skills. Detail oriented with excellent organizational skills. Proficiency in using computers, software, and web-based applications in a previous administrative setting. Fluency in Spanish is a plus. 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.
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