Demo

Clinical Research Associate

MW Partner
Durham, NC Temporary
POSTED ON 3/19/2025
AVAILABLE BEFORE 4/18/2025

Job Description

Job Description

MW Partners is currently seeking a Clinical Research Associate to work for our client who is a global leader in the pharmaceutical industry.

Responsibilities and duties :

  • Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation / study start-up
  • Conducts / oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine clinical trial protocol, GCP / ICH Guidelines and all applicable regulatory requirements compliance and in agreement with the Clinical Monitoring Plan for the study
  • Prepares telephone contact reports, confirmation letters, site visit reports (Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits), and follow-up letters to accurately and completely document site status and activities in agreement with the Clinical Monitoring Plan for the study
  • Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity
  • Reconciles clinical supplies and drug accountability records at study sites
  • Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required
  • Reviews, clarifies, and obtains, data changes via query resolutions with site personnel
  • Conducts monitor training

Requirements :

  • Tracks study specific tasks and progress of the trial
  • Communicates and interacts with relevant study personnel, including : develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy
  • Assists with effective and timely audit / inspection responses
  • Performs regulatory document review and approval for IP release
  • Monitors processes for distribution and tracking of SAE's, safety documentation, and pregnancies
  • Collaborates with data management to resolve queries
  • Facilitates investigator site payments, as applicable
  • Reviews / creates / tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation
  • Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). Reviews and tracks study documents, including : project files both electronically and in the Trial Master File and Project Status Reports.
  • Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). Prepares accurate and complete meeting minutes for various meetings.
  • For a confidential discussion or to find out more, contact Snehita on 909-206-2714 or apply now.

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