• Clinical Study Associate I (TMF)

    System One (Basking Ridge, NJ)


    Job Title: Clinical Study Associate I (TMF)

     

    Schedule: Monday - Friday

     

    Type: Contract

    Overview

    Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. If you want to be a part of this groundbreaking work, apply today!

    Responsibilities

    + Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Quality Oversight measures.

    + Support and assist the transmittal of trial and site level document to the Document Control Center (DCC) in support of the Trial master File (TMF).

    + Reconcile the TMF document trackers generated by the CRO with the document archive.

    + Bring issues with the reconciliation to the attention of the supervisor.

    + Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor.

    + Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).

    Requirements

    + Bachelors degree

    + Minimum of 1-year relevant experience is required.

    + Veeva and or Oncology experience is a plus.

    + Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO).

    + Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.

    + Basic oral and written communication skills.

     

    Ref: #568-Clinical

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.