Clinical Study Assistant

Highly Competitive
  1. Permanent
  2. Clinical Trial Assistant (CTA), Clinical Research Associate (CRA)
  3. United States
Jacksonville, Florida
Posting date: 28 Mar 2019
CR.MJ.22406_1553769397

ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Clinical Study Assistant position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Florida-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.

The Clinical Study Assistant will provide administrative and organization support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP) as guidelines, standards, federal regulations, and SOPs. They will closely collaborate with other members within Clinical R&D.

Job Responsibilities:

  • Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
  • Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
  • Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications, and sharing pertinent information with clinical trial team members and investigative sites.
  • Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site throughout the duration of assigned clinical trials.
  • Entering and maintaining required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required.
  • Setting-up of Trial Master File, investigator study file binders, and regulatory document collection.
  • Supporting user acceptance testing, reviewing Electronic Data Capture (EDC) reports and data listings, and discussing findings with CRA.
  • Coordinating and planning investigator meetings, site training, and other company functions.
  • Monitoring EDC for assigned Studies.
  • Co-monitoring internal or external Clinical Study Site.
  • Interacting with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate.
  • Supporting the successful execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures.

Skills and Requirements:

  • A Bachelor's degree or higher from an accredited institution.
  • 1-2 years' Clinical Study Assistant.
  • Knowledge of FDA guidelines, regulations and/or Good Clinical Practice highly desirable.
  • Demonstrable multitasking, project management, and execution skills.
  • Willingness and availability to travel on company business.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Mary Jacobs at +267-477-4800 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-MJ1

close