Senior Clinical Study Associate - Oncology in Bernards, NJ at Apex Life Sciences

Date Posted: 2/14/2018

Job Snapshot

Job Description


Duties:  

  • Assist in planning and execution of clinical studies, under the close supervision of a Senior 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.
  • Provide clinical administrative support to study teams in regards to interacting with the Contract Research Organizations (CROs) and other vendors conducting the study
  • Support and assist the transmittal of trial and site level document to the internal 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.
  • Provide clinical administrative support to the study teams including 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 internal Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
  • Works with Insurance Brokers to obtain study site Insurance
  • Analyze site metrics reports to identify potential areas of concern and bring to supervisor’s attention.
  • 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).

Skills:     

  • An Associate’s Degree, or Nursing background desired; Bachelor’s degree or higher preferred.
  • 5+ years of experience as a Clinical Study Associate or closely related a must
  • Previous Clinical trial experience working with CROs conducting or supporting oncology Trials Phase I- III highly desired
  • Experience in Clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO) will be considered
  • Experience in a medical environment (e.g. as a Study Site Coordinator) is desired
  • Working knowledge of processes related to clinical studies, regulatory issues, assigned CRO operations, and compliance practices desired