Lead Clinical Research Associate – Hema/Oncology (Northeast US)


Category: Clinical Research Associate
Job #: 10641
Location: Northeast US
Job Type: 1099 / Regional Homebased
Rate / Salary Range: Competitive Hourly Rate

One of our Sponsor partners is looking for a Lead CRA to provide management to one or more Hema / Oncology projects. Qualified candidates will have a degree in Life Sciences, at least 5 years’ experience monitoring, at least 2 years’ experience monitoring Hema / Oncology projects as well as experience in a Lead role. At least 25% utilization is required, and more utilization will be available in 1st quarter 2021 as new projects launch with the company.

Job Responsibilities:
  • Provide training to other CRAs on the study protocol, study conduct, CRF completion and data management expectations
  • Ensure essential document collection for completeness per regulatory requirements
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs
  • Manage one or multiple studies
  • Monitor product supplies/accountability
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities
  • Review in-house data and study tables
  • Mentor, coach and provide guidance to clinical staff as appropriate
  • Effectively review trip reports as per annotated report, protocol, Sponsor SOPs and monitoring plan, ensuring errors are minimized, reports are consistent across visits and sites and adhere to the highest standards of quality
  • To observe and escalate safety trends in patients as identified in trip reports
  • To follow up on action items and protocol deviations and to be a liaison between CRA, CTM and PM for timely resolution of issues
  • Track processing time throughout review cycle, ensuring turnaround time of the trip reports adhere to Sponsor SOPs
  • Regular oversight of tracking systems to ensure key metrics, e.g. MVR and FUL timelines, action Items and other quality metrics are being met and followed
  • Compile information and provides status updates to monitoring management and to monitoring staff, as requested
  • Where required, attend project meetings and actively provide suggestions for improvement of quality of reports, provide feedback for timely and appropriate resolution of action items and report trends
  • Liaise with CTM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety
  • Ensure all necessary trainings, required to improve job performance and knowledge, are completed in a timely manner
  • Contribute towards quality improvement and risk management plans to minimize impact on project objectives and deliverables, and patient safety and show consistent improvement in metrics
  • May be involved in the start-up of new studies by providing input on the visit report template
Job Qualifications:
  • At least 25% Utilization
  • Minimum 2 years’ experience monitoring Hema/Oncology projects
  • Minimum 5 years’ experience as a fully dedicated regional, home based field monitor (having gained that experience from a CRO or Pharma)
  • Experience in a report review role (title unimportant)
  • Minimum Bachelor’s degree in a science field required with medical background preferred
  • Long term contract (minimum one year, with potential to extend to 3 years)
  • Hourly rate (1099) between 80-90 (covered door to door)

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