Clinical Research Associate

Summary

Under direction of the Manager of Grants & Special Projects, the Clinical Research Associate coordinates all aspects of clinical trials within the assigned unit at the Adult Immunology Clinic, Highland Campus. In consultation with providers and other clinical personnel, the associate is responsible for selecting, implementing and monitoring clinical trials, educating, and when appropriate, enrolling patients into the various programs. Performs related duties as required.

• CLINICAL TRIALS: Responsible for assisting in the selection and administration of appropriate clinical research trials by reviewing studies, adhering to federal regulations and ICH Guidelines with an emphasis on good clinical practice and clinical safety data management. Administers informed consent and enrolls participants into clinical trials.
• INSTITUTIONAL REVIEW BOARD (IRB): Acts as departmental representative at the Institutional Review Board’s Human Subject Committee meetings. Presents all new research projects to the committee, modifies, renews and closes out projects, reports serious adverse events and protocol violations, and submits drug and/or device safety reports to the IRB.
• REGULATORY: Organizes research team and meets as needed, maintains current CVs and licenses for all study investigators, updates regulatory binders, provides central protocol and drug information to departments, educates hospital personnel regarding protocols and screening requirements, reports serious adverse events to the study sponsor and FDA, ensures compliance with federal and state laws regarding research and confidentiality, and collaborates with nursing staff to comply with external guidelines and accreditation parameters (JCAHO, Title 22, HCFA, OSHA, etc.).
• PRESENTATION AND PUBLICATIONS: Assists investigators in preparing manuscripts and designing posters and oral presentations for annual conventions, conferences and trainings, and performs searches through existing medical literature.
• ADMINISTRATIVE/FISCAL: Organizes research team, maintains current CVs and licenses for all sub–investigators and binders for each protocol, acts as point person for budgetary and administrative issues, prepares and negotiates study budgets, monitors income and expenses, requests and administers patient compensation and petty cash, provides scheduled accounting of research funds to department directors, interacts with AHS staff professionally, supervises research personnel to ensure compliance with protocols, and obtains, interviews and directly supervises research department volunteers and medical students on research elective rotations.

• Education: Bachelor’s Degree (180 quarter units or 120 semester units) with major coursework in health and human sciences, biology, or a field related to the work. (Additional experience may be substituted for the education on a year-to-year basis.)
• Minimum Experience: Experience and expertise in medical research gained through hands‑on experience in a medical or scientific setting, as a graduate or medical student, or other medically trained individual. Typically equal to the equivalent of two years of full‑time experience as a Clinical Research Associate or an equivalent level position at a public hospital, medical center or HMO.
• Required
  
  Licenses/Certifications:
  
  BLS – Basic Life Support Certification issued by the American Heart Association (AHA).

Alameda Health System