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Hybrid Clinical Study Associate II

2 months ago

Basking Ridge, United States The Fountain Group Full time

Details for the position are as follows:

  • Location: Basking Ridge, NJ
  • 12-month contract to start with the strong possibility of extension or conversion depending on performance.
  • Hybrid- must be able to come into office 1-4 times a week(more likely 1-2 depending on study needs).
  • Candidate must be physically located within a 1 hour -1 hour and 30 min. from Basking Ridge, NJ.
  • Rate: $35-42 an hour.

Job Description:

  • Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager 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.
  • Key focus is on providing clinical trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).
  • Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.
  • Distribute key study documents to the CRO and vendors as appropriate.
  • Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
  • Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
  • Support Fair Market Value process in evaluating study budgets
  • Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.
  • Compile and maintain a monitoring review spreadsheet.
  • Ensure the Trial Master Files are inspection ready.
  • 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 your supervisor.
  • Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
  • Analyze study site metrics reports to identify potential areas of concern and bring to supervisor’s attention.

Required Skills:

  • A bachelor’s degree (preferred in Life Sciences) with relevant clinical development experience.
  • Experience considered relevant includes 3 years of clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company.