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Clinical Trial Lead

Health Decisions, Inc.


Location:
Durham, North Carolina
Date:
07/27/2017
2017-07-272017-08-26
Job Status:
Full Time
Categories:
  • Clinical Operations
Health Decisions, Inc.
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Job Details

Health Decision is a specialty CRO that utilizes a broad expertise across Women’s Health research with adaptive design and adaptive operational capabilities to deliver medicines and diagnostics of value to women worldwide. We are seeking a Clinical Trial Lead in our Durham Headquarters to lead the clinical monitoring team (Clinical Research Associates [CRAs] andIn-house Clinical Research Assoicate [IHCRAs]), to ensure that projects are completed in accordance with the Task Order, client, and Health Decisionsexpectations. 

Responsibilities

 

  • Provides oversight the feasibility and investigator selection,monitoring projections, including resource and visit projections, as well as, monitoring report review
  • Manages study training for clinical monitoring team, overall site and CRA metrics
  • site assignments and subject closeout
  • Assist project management with resource and utilization assessments, timeline adherence, quality assurance, and financial adherence as it pertains to clinical monitoring team activities
  • Act as secondary sponsor contact
  • Is a resource and point of escalation for protocol and process questions from clinical monitoring team members
  • Ensure site and in-house monitoring is occurring according to the monitoring plan and study timelines
  • Create and modify study documents when needed
  • Present at Investigator Meetings
  • Review and approve expense reports
  • Plan and facilitate site and CRA meetings
  • Provide study status updates to the PM and escalate study issues
  • Provide feedback on clinical team member performance to Line Managers.

Qualifications

We are looking for a BA/BS degree (preferably in a life science) with aminimum of 5 years of experience as a CRA or clinical trial lead. Progressive experience in the conduct of clinical research including ICH-GCP requirements, drug/device development process, and regulatory complianceis required; Strong leadership skills and demonstrated ability to manage others; Strong mentorship skills and advanced monitoring skills to ensure quality of monitoring for the clinical team is a must; Excellent written, oral communication, organization and presentation skills; Proficient computer skills, especially in Microsoft Office, and the ability to learn other applications.

 

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