Clinical Research Associate, Full Time, Benefited, Days, 8hours, 1.0fte

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, 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 : NOTE : The following are the duties performed by employees in this classification. However, employees may perform other related duties at an equivalent level.

Not all duties listed are necessarily performed by each individual in the classification.

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, enrollment of participants into clinical trials.

INSTITUTIONAL REVIEW BOARD (IRB) : Acts as departmental representative at Institutional Review Board’s Human Subject Committee meetings.

Presents all new research projects to the committee. Modifies, renews and closes out all appropriate research projects. Reports all serious adverse events and protocol violations.

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 for each research study. Provides central protocol and drug information to departments. Educates hospital personnel regarding protocols and screening requirements.

Reports serious adverse events to study sponsor and FDA, when appropriate. Ensures compliance with all federal and state laws regarding research and confidentiality.

In collaboration with nursing staff, assures 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 : Assists investigators in the preparation of manuscripts and the design of posters and oral presentations for annual conventions, conferences and trainings, when appropriate.

Performs searches through existing medical literature.

ADMINISTRATIVE / FISCAL : Organizes research team (nurses, co-investigators) and meets with team, as needed. Maintains current CVs and licenses for all sub investigators and binders for each protocol.

Acts as the point person for budgetary and administrative issues. When appropriate, prepares and negotiates study budget.

Monitors and accounts for all study related income and expenses. Requests and administers patient compensation and petty cash.

Provides scheduled accounting of research funds to department directors. Interacts with AHS staff in a professional and courteous manner.

Supervises research personnel to ensure compliance with protocols. Obtains, 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 field related to the work.

Additional experience as outlined below may be substituted for the education on a year-to-year basis.)

Minimum Experience : Possess experience and expertise in medical research. Experience and expertise can be gained by 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 equivalent level position at a public hospital, medical center or HMO.

Required Licenses / Certifications : BLS - Basic Life Support Certification issued by AHA-American Heart Association.

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