Medical Psychiatry Research Assistant(6 Month Fixed Term)

Stanford UniversityStanford, CA
4d$32 - $38Onsite

About The Position

The Division of Medical Psychiatry within the Department of Psychiatry and Behavioral Sciences at Stanford University's School of Medicine is seeking a 6 month Fixed Term Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of one or more clinical studies. The CRCA will work under close direction of the Division Chief. Interested candidates should include a cover letter and copy of their CV with their application. 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. - 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.

Requirements

  • 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.
  • Strong interpersonal skills.
  • Proficiency with Microsoft Office.
  • Knowledge of medical terminology.

Nice To Haves

  • Experience in clinical research with adult human subjects - highly desirable. The RA will have direct patient contact on a daily basis.
  • Experience with research data processing and analysis - highly desirable.
  • Experience in preparing data for scientific publication - highly desirable.
  • Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Responsibilities

  • 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.
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