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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.
Educational Qualifications: High School Diploma and 1 or more years of medical office experience is required. Medical Assistant certification or BA/BS in a science related field and/or 2+ years of research experience is preferred.
- Familiarity with GCP and FDA/ICH regulations;
- Good knowledge of medical terminology;
- Microsoft Office skills
- CPR certification (if an MA)
About Clinical Research Advantage:
Clinical Research Advantage is a leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. CRA has completed over 2,000 clinical trials in its 20 years. CRA is comprised of community based Investigators plus an experienced staff of Clinical Research Coordinators in its 70+ site network across the US. The key to our success has been the development of research departments within established medical practices. Our research staff is positioned in the clinic, which affords CRA rapid recruitment of reliable, qualified subjects into clinical trials. Our expertise continues throughout the trial, providing full execution of the protocol with complete and accurate data. CRA enjoys a strong reputation for quality and is focused on patient care.
In 2011 CRA was voted one of the 25 Top Workplaces for Women by AZ Magazine;
In 2012 CRA was named "Best Clinical Site Network" by the ViE Awards;
In 2013 CRA was named "Fastest Growing Company" by Arizona's Most Admired Companies; and
In 2013 CRA was named the second "Fastest Growing Company" by the ACE Awards!
Posted 4 years ago
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