Clinical Research Operations Specialist I

Company: Stanford Medicine
Location: Santa Cruz
Posted on: January 15, 2022

Job Description:

The Stanford Center for Clinical Research (SCCR), in collaboration with the Stanford Departments of Medicine, Neurosurgery, Bioengineering and Radiology, is conducting large, innovative longitudinal studies. SCCR is seeking to hire a Clinical Research Operations Specialist I to support duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study Operations Manager. SCCR provides infrastructure and research support to Stanford clinical research investigators. Its mission is to conduct and promote high-impact, innovative clinical research to improve human health. The Clinical Research Operations Specialist I will work within a multidisciplinary team, including physicians, athletic trainers, and coaches; and have direct interaction with participants. The Clinical Research Operations Specialist I is required to have the ability to multi-task in a high-energy environment. This position may involve traveling to study sites and being able to attend the athletic games and practice sessions. The Clinical Research Operations Specialist I is required to have flexibility in their work schedule and outstanding communication and organizational skills with attention to detail. The study visits may occur in the evenings and occasionally during weekends. The Clinical Research Operations Specialist I will be responsible for ensuring compliance with federal, state, local, and sponsor regulations and work under the direction of their supervisor. Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• 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. 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. 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.
      • Working toward certification(s) to perform basic patient measurements and tests, such as phlebotomy and EKG. WORKING CONDITIONS:
        • Occasional evening and weekend hours. 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 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, http://adminguide.stanford.edu/. Why Stanford is for You Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
              • Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
              • A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
              • A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
              • Discovery and fun. Stroll through historic sculptures, trails, and museums.
              • Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. 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. As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy. Additional Information
                • Schedule: Full-time
                • Job Code: 4924
                • Employee Status: Regular
                • Pay Grade: F
                • Requisition ID: 92544 As an organization that receives federal funding, Stanford University has a COVID-19 vaccination requirement that will apply to all university employees, including those working remotely in the United States and applicable subcontractors. To learn more about COVID policies and guidelines for Stanford University Staff, please visit https://cardinalatwork.stanford.edu/working-stanford/covid-19/interim-policies/covid-19-surveillance-testing-policy

Keywords: Stanford Medicine, Santa Cruz , Clinical Research Operations Specialist I, Healthcare , Santa Cruz, California