Clinical Research Advantage, Inc. (CRA) is a leader in outsourced trial management services to the pharmaceutical, biotechnology and medical device industries. CRA has completed over 1,800 clinical trials in its 20 years. CRA is comprised of community based Investigators plus an experienced staff of Clinical Research Coordinators. CRA currently operates from its 33 site network across seven states. 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. At Clinical Research Advantage we understand that our greatest asset is the skills and talents of our people. It's our people that set us apart!
Clinical Research Advantage, Inc is looking for a Research Assistant for our Council Bluffs, IA location!
The Research Assistant (RA), as delegated by the Site Manager, executes daily clinical research activities according to CRA’s SOPs, GCP and FDA/ICH guidelines. Executes informed consent process and monitors patient status; collects and organizes research data; The Research Assistant must also be able to perform clinical tasks (i.e. phlebotomy, EKGs, vital signs, etc.). The main job functions include:
1. Assists the Research Coordinators in their responsibilities by doing the following:
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;
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;
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.
A Medical Assistant certification or Bachelor's degree and 1+ years of research or medical assisting experience, or an equivalent combination of education and experience, is required;
Should have experience with vitals, vaccines, phlebotomy and lab processing;
Must be proficient with Microsoft office applications (Outlook, Word and Excel) as well as internet based applications;
Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
Must have excellent communication, teamwork and problem solving skills;
Must be professional, possess a high degree of self-motivation and have a strong work ethic.
Must have the ability to adapt and take-on additional tasks as requested;
Must be capable of recognizing, and have the willingness, to resolve errors and issues;
Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
Join Clinical Research Advantage as we expand! Become an important part of a well-respected and growing company that believes the details of your career are every bit as critical as the work you do.
In 2011 CRA was voted one of the 25 Top Workplaces for Women by AZ Magazine and in 2012 CRA was named "Best Clinical Site Network" by the ViE Awards!
You'll enjoy competitive compensation and an exceptional benefits package that includes: Medical, Dental and Vision Insurance, Life and AD&D Insurance, disability, 401K Plan, a competitive program of time off and more.