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.

Duties & Essential Job Functions

• 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 enroll participants into clinical trials.
• Institutional Review Board (IRB): Act as departmental representative at IRB Human Subject Committee meetings. Present all new research projects to the committee, modify, renew and close out appropriate research projects, report all serious adverse events and protocol violations, and submit drug and/or device safety reports to the IRB.
• Regulatory: Organize research team and conduct meetings as needed. Maintain current CVs and licenses for all study investigators and update regulatory binders for each study. Provide central protocol and drug information to departments, educate hospital personnel regarding protocols and screening requirements, and report serious adverse events to study sponsors and the FDA when appropriate. Ensure compliance with all federal and state laws regarding research and confidentiality, and collaborate with nursing staff to meet external guidelines, statutory and accreditation parameters (JCAHO, Title 22, HCFA, OSHA, etc.).
• Presentation and Publications: Assist investigators in preparing manuscripts and designing posters and oral presentations for annual conventions, conferences, and trainings. Perform literature searches as needed.
• Administrative/Fiscal: Organize research team (nurses, co‑investigators) and conduct meetings. Maintain current CVs and licenses for all sub‑investigators and protocol binders. Serve as 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, and provide scheduled accounting of research funds to department directors. Interact professionally with AHS staff, supervise research personnel to ensure protocol compliance, and obtain, interview, and directly supervise research department volunteers and medical students on research elective rotations.

Minimum Qualifications

• Education: Bachelor’s Degree (180 quarter units or 120 semester units) with major coursework in health and human sciences, biology, or a related field. Additional experience may be substituted for education on a year‑to‑year basis.
• Experience: Experience and expertise in medical research, typically equivalent to two years of full‑time experience as a Clinical Research Associate or equivalent level position at a public hospital, medical center, or HMO. Experience can be gained through hands‑on work in a medical or scientific setting, graduate or medical school, or other medically trained roles.

Required Licenses/Certifications

• BLS – Basic Life Support Certification issued by the American Heart Association (AHA).

Pay

The pay range for this position reflects the base pay scale for the role at Alameda Health System. Final compensation will be determined based on factors such as experience, education, skills, licensure, certifications, departmental equity, collective bargaining agreements, and operational needs. $49.48/hr – $60.16/hr