Clinical Study Associate I (TMF)

Company: Joul--
Location: Basking Ridge
Posted on: May 11, 2025

Job Description:

Job Title: Clinical Study Associate I (TMF)

If you are interested in applying for this job, please make sure you meet the following requirements as listed below.
Location: Basking Ridge, NJ
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

Keywords: Joul--, Stamford , Clinical Study Associate I (TMF), Healthcare , Basking Ridge, Connecticut