Clinical Research Associate I

at  Eisenhower Health

• Job Objective: A brief overview of the position.
• The position will be responsible for assisting in the running of Clinical Trials.

EDUCATION

• Required: Bachelor’s degree or two (2) years’ research experience in lieu of degree; Completion of CITI Good Clinical Practice (GCP) for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course (www.CITIprogram.org)
• Preferred: Bachelor’s degree in Clinical Research, Nursing or Administration

EXPERIENCE

• Required: One (1) year of healthcare experience or successful completion of paid six (6) month Research Internship at Eisenhower Health

1. Demonstrates compliance with Code of Conduct and compliance policies, and takes action to resolve compliance questions or concerns and report suspected violations.
2. Completes patient screening for eligibility to research protocol. Records results in logs and Epic.
3. Completes registration/randomization to protocol. Schedules treatment, specimen collection, imaging studies and/or other tests/exams.
4. Completes patient recruitment and follow-up.
5. Completes case report forms (CRFs):
   o Ensures adequate source documentation in the medical record to support clinical trial.
   o Abstracts data from Epic (source data) and/or obtains medical records to complete CRFs.
   o Contacts patient, as needed, to collect data and documents in Epic
   o Completes data entry in electronic data capture (EDC) or specified databases. Resolves queries.
6. Reports and communicates to the sponsor/CRA/monitor/IRB.
7. Reports serious adverse events.
8. Handles & maintains investigator files.
9. Schedules meetings with physicians, creates agendas, and takes minutes.
10. Sends letters and/or telephones/communicates with patients and physicians regarding study results.
11. Performs other duties as assigned.
    Location: Eisenhower Health · Research-Oncology
    Schedule: Full Time, Varies, 8 Hour Shif