Clinical Research Coordinator Associate

Company: Stanford Medicine
Location: Berkeley
Posted on: January 15, 2022

Job Description:

Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical research studies in the division of neuro-ophthalmology, Department of Ophthalmology. This individual will be involved with all aspects of observational human subjects research from project planning, to subject recruitment and consent, to data analysis and dissemination. This individual will work under close direction of the principal investigator, Dr. Heather Moss. 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 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 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: Occasional evening and weekend hours. Additional Information
      • Schedule: Full-time
      • Job Code: 4924
      • Employee Status: Regular
      • Pay Grade: F
      • Requisition ID: 92139 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, Berkeley , Clinical Research Coordinator Associate, Accounting, Auditing , Berkeley, California