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Clinical Research Coordinator

FindingPharma New Orleans, LA

Pharmacy SupvFld Mgmt

CVS Health New Orleans, LA
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Location: New Orleans, LA
Application Deadline: None
Type: Not specified
Career Level: Entry Level
Salary Range: Not specified
Number of Jobs: 1
Relocation Available: No

Industries

Pharmaceutical,

Description

Clinical Research Advantage, Inc is looking for a motivated & dependable research professional to join our team as a Research Assistant!

Responsibilities
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 RA sssists the Research Coordinators in their responsibilities by doing the following:

  1. Performs basic screening of patients for study enrollment;
  2. Enrolls patients in studies;
  3. Performs patient follow-up visits;
  4. Documents study procedures in source clinic charts;
  5. Updates and maintains required logs and charts;
  6. Prepares schedules;
  7. Organizes work area;
  8. Performing audits for quality control purposes;
  9. Accurately processes and sends lab specimens per protocol specifications;
  10. Completes case report forms ensuring accuracy of data and reporting of adverse events to sponsor;
  11. Draws blood, takes vital signs, accurately completes EKG tests; and becomes thoroughly familiar with the protocol, case report form, informed consent, source documentation and patient diary (when applicable), for the research studies;
  12. Adheres to GCP, ICH, HIPAA, FDA Regulations and SOPs and maintain ongoing regulatory documents;
  13. Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner;
  14. Generates reports for supervisor on patient enrollment and tracking;
  15. Maintains accountability of own ongoing professional growth and development;
  16. Performs necessary functions as approved by Clinical Research Advantage, for the conduct of clinical research;
  17. Maintains strict confidentiality of patients, employees and company information at all times and adheres to HIPAA Guidelines; and
  18. May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.

Requirements
Certified Medical Assistant and/or a BA/BS in a science related field. More than 1 year experience in clinical research may be substituted.
Experience/Training:

  • Medical Assistant Certification preferred with phlebotomy, EKG and blood pressure experience preferred ;
  • Familiarity with GCP and FDA/ICH regulations;
  • Good knowledge of medical terminology;
  • Microsoft Office skills
  • CPR certification (if an MA)


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