Clinical Research Associate
Company: Alameda Health System
Location: San Leandro
Posted on: November 22, 2021
Under the direction of the Clinical Research Leader, the Clinical
Research Associate will coordinate all aspects of clinical research
into opioid treatment. In consultation with providers and other
clinical personnel, you will be responsible for selecting,
implementing and monitoring clinical trials, educating, and when
appropriate, enrolling patients into the various programs.
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
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
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 ACMC 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.
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. Bachelor's Degree 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, and the equivalent to two years
of full-time experience as a Clinical Research Associate or
equivalent level position at a public hospital, medical center or
Keywords: Alameda Health System, San Leandro , Clinical Research Associate, Healthcare , San Leandro, California
Didn't find what you're looking for? Search again!