Research Assistant

Assists the Research Coordinators in their responsibilities by doing the following:

1. Performs basic screening of patients for study enrollment; Enrolls patients in studies; Performs patient follow-up visits; Documents study procedures in source clinic charts; Updates and maintains required logs and charts; Prepares schedules; Organizes work area; Performing audits for quality control purposes; Accurately processes and sends lab specimens per protocol specifications; Completes case report forms ensuring accuracy of data and reporting of adverse events to sponsor; Draws blood, takes vital signs, accurately completes EKG tests; and

  2. Becomes thoroughly familiar with the protocol, case report form, informed consent, source documentation and patient diary (when applicable), for the research studies;

3. Adheres to GCP, ICH, HIPAA, FDA Regulations and SOPs and maintain ongoing regulatory documents;

4. Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner;

5. Generates reports for supervisor on patient enrollment and tracking;

6. Maintains accountability of own ongoing professional growth and development;

7. Performs necessary functions as approved by Clinical Research Advantage, for the conduct of clinical research;

8. Maintains strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines; and

9. May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.