Clinical Research Advantage, Inc is looking for a motivated & dependable research professional to join our team as a Research Assistant! This position will be located in one of our research sites in Omaha, Nebraska.
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:
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)
To apply for this position: Please visit our website at www.crastudies.com and visit the Careers page, or cut and paste this link into your browser: https://home.eease.adp.com/recruit/?id=1657311