Clinical Research Associate

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, is responsible for selecting, implementing, and monitoring clinical trials, educating, and when appropriate, enrolling patients into the various programs.

Responsibilities

• Clinical Trials: Assist 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. Administer informed consent and enrollment of participants into clinical trials.
• Institutional Review Board (IRB): Act as departmental representative at Institutional Review Board’s Human Subject Committee meetings. Present all new research projects to the committee. Modify, renew, and close out all appropriate research projects. Report all serious adverse events and protocol violations. Submit drug and/or device safety reports to the IRB.
• Regulatory: Organize research team and meet as needed. Maintain current CVs and licenses for all study investigators. Update regulatory binders for each research study. Provide central protocol and drug information to departments. Educate hospital personnel regarding protocols and screening requirements. Report serious adverse events to study sponsor and FDA, when appropriate. Ensure compliance with all federal and state laws regarding research and confidentiality. In collaboration with nursing staff, assure that operations are in compliance with external guidelines, statutory, and accreditation parameters including JCAHO, Title 22, HCFA, OSHA, and other laws/regulations.
• Presentation and Publications: Assist investigators in the preparation of manuscripts and the design of posters and oral presentations for annual conventions, conferences, and trainings, when appropriate. Perform searches through existing medical literature.
• Administrative/Fiscal: Organize research team (nurses, co-investigators) and meet with team as needed. Maintain current CVs and licenses for all sub-investigators and binders for each protocol. Act as the point person for budgetary and administrative issues. Prepare and negotiate study budgets when appropriate. Monitor and account for all study-related income and expenses. Request and administer patient compensation and petty cash. Provide scheduled accounting of research funds to department directors. Interact with AHS staff in a professional and courteous manner. Supervise research personnel to ensure compliance with protocols. Obtain, interview, and directly supervise research department volunteers and medical students on research elective rotations.

Requirements

• 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.
• Experience: Possess 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 two years of full-time experience as a Clinical Research Associate or equivalent level position at a public hospital, medical center, or HMO.
• Licenses/Certifications: BLS - Basic Life Support Certification issued by AHA-American Heart Association.

Pay

$49.48/hr - $60.16/hr

Benefits

Alameda Health System offers eligible positions a generous comprehensive benefits program.