Senior Clinical Operations Coordinator

Company: Randstad USA
Location: Cherry Hill
Posted on: June 23, 2022

Job Description:

Responsibilities:May include but not limited to the following:

• As required, maintain local files as applicable (e.g., maintenance of the local regulatory files as required by the local regulatory requirements and Standard Operating Procedures (SOPs), resource training files).
• Serve as first point of contact for regionally-based Clinical Research Associates (CRAs) and clinical study site personnel, as required for project.
• As required, devise and/or employ established tracking mechanisms to accurately and effectively track and report study activities and deliverables.
• May work across multiple projects and must be able to work effectively in a team setting and/or matrix environment.
• Assist the Country Clinical Monitoring Team (CCMT) as needed to support assigned projects.Provide general study support including but not limited to the following:
  • Conduct administrative and logistical tasks related to clinical study set-up, active conduct and closeout in support of the CCMT.
  • Organize and ensure timely shipment of documents and supplies to CRAs, Study Start-up Vendor(s), investigational sites and Headquarter (HQ) per CCMT requirements.
  • Transmit, collate, track and file documents and data for the CRA/CCMT and provide alerts relative to missing, inaccurate or incomplete elements.
  • Communicate and collaborate with local study coordinator and/or regulatory coordinator to ensure timely and accurate completion of all required documents for submission to IRB/REB and/or other local committees, as applicable for study. For Central IRBs, collaborate with the vendor to ensure timely submissions and procurement of required approvals for study start-up. As necessary, track submission progress and generate status update reports for CCMT.
  • Help ensure timely Investigational Materials/Study Drug release to investigational sites via collection, quality review and preparation of documents required for release approvals.
  • Perform quality checks and upload documents to the electronic Trial Master File (eTMF).
  • Regularly input/update and maintain accuracy and currency of data in the CTMS.
  • May act as Super User of CTMS, lending technical system support to a country / cluster of countries, if required.
  • Prepare the Study Drug release, i.e., collect, quality check and prepare documents for Study Drug approval and release in collaboration with CRAs
  • Assist in identifying and implementing best practices and continuous process / systems improvement plans.
  • May be requested to attend monitoring visits with CRAs to collect critical documents, if needed.Position Requirements:Education:
    • Associate degree (or equivalent) required at a minimum; 4-year degree in a scientific or health care discipline preferred Experience:
      • 3 - 4+ years' relevant work experience in clinical trials operations and a working knowledge of ICH GCP, global standards, local laws and regulations.Special Skills:
        • Proficiency in Office WORD, EXCEL, POWERPOINT a must. Working knowledge of electronic data capture (EDC) and Clinical Trial Management Systems (CTMS) preferred.
        • Demonstrated ability to multitask and focus on multiple deliverables simultaneously.
        • Must possess strong communication skills (both written and verbal).

Keywords: Randstad USA, Cherry Hill , Senior Clinical Operations Coordinator, Healthcare , Cherry Hill, New Jersey