Clinical Trial Associate

Rochelle Park, New Jersey

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Job Description

TKL Research is a full-service, international Clinical Research Organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. We provide comprehensive clinical trial management services for Phase 1-4 clinical research studies, including an inpatient Phase 1 facility and outpatient specialized research clinics.

We are seeking a highly motivated Clinical Trial Associate for our growing organization!

In this role, you will assist the project management team with administrative activities associated with the conduct of multi-center clinical trials.  The Clinical Trial Associate (CTA) may travel up to 30% to investigator meetings or for other business related reasons.

Responsibilities include, but are not limited to:

  • Communicate with the project team (Sponsor, CRAs, vendors, etc.).
  • Communicate with sites on issues escalated related to clinical supplies.
  • Oversee order of clinical supplies and distribution to sites.
  • Prepare, review and approve site regulatory documents.
  • Prepare IRB submissions and communicate with the IRB re: submissions.
  • Forward regulatory packets to Sponsor.
  • Create and maintain Trial Master File and/or the CTMS under guidance of project manager or delegate.
  • Prepare study regulatory binders and distribute to sites, if needed.
  • Assist Senior Project Managers, Project Managers or Assistant Project Managers with the following:
    • Update standard study logs and tracking forms and customize for each site.
    • Prepare materials (i.e., binders, presentations) for investigator meetings.
    • Attend Investigator Meetings as needed.
    • Update enrollment activities (update Patient Tracking Logs weekly).
    • Update Status Reports (forward to Sponsor and project management team) on a frequency as needed by the sponsor.
    • Prepare newsletters, if applicable, and distribute to sites and Sponsor.
    • Attend team meetings (prepare and distribute agenda and minutes).
    • Enter and maintain data in the CTMS system per the guidance of the project team.
    • Function as primary communicator with investigative sites on budgets, regulatory documents and informed consent elements, as required by assigned Clinical Project Manager.
  • Miscellaneous duties, as necessary, in support of Clinical Project Management initiatives and TKL business priorities and objectives.




Skills/Requirements

Minimum Bachelor’s degree, preferably in the sciences or health related field.  Ideal candidate will have at least 2 years of relevant experience with a clinical research organization and/or pharmaceutical company. Must have the ability to understand technical details and scientific concepts related to FDA regulations and GCP/ICH guidelines as they apply to the conduct of clinical research. Strong written and verbal communication skills. Excellent organizational skills. Ability to travel (e.g., Investigator’s Meetings). Working knowledge of Microsoft Office Suite is required. This is a full-time position based in our Rochelle Park, NJ headquarters.

We offer a competitive compensation package for full time employees, commensurate with your background and experience, including full benefits, 401(k) with match and a profit sharing plan.

www.tklresearch.com

 

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