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Clinical Team Lead

Clinical Team Lead

ID 
2017-1365
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Clinical Team Lead is integral to driving project success. This position will independently manage and monitor clinical trial sites, and will function as the Lead CRA on select projects.  In the Lead role, this position will be responsible for providing direction to and training for other CRAs assigned to those projects.  In addition, the clinical team lead is responsible for the oversight of all operational aspects related to the planning and management of site performance

The Clinical Team Lead will be responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.

 

This is an office based opportunity. Candidates must be willing to relocate to the Raleigh/Durham/Chapel Hill area and reside within a 1 hour commute distance of the office.

 

Required to travel 25% on average.

Responsibilities

Responsibilities and duties include, but are not limited to:

  • Proactively drive project success, including working closely with Project Managers to develop and implement enrollment strategies
  • Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations.
  • Develops monitoring tools and plans.
  • Determine and drive the study start up process (track and report progress, review data) ensuring that all sites are selected and supplies provided in accordance with study start expectations.
  • Provide skilled review of study protocols and other study materials (e.g. CRF)
  • Monitors clinical operations timelines, metrics and activities
  • Provides status updates to project management and sponsors.
  • Leads regular clinical team teleconferences
  • Work effectively with Site Study Coordinators
  • Participate in the RFP process, including internal and external business development meetings
  • Reviews monitoring visit reports and ensures finalization is within contractual timeline.
  • May assist Project Managers with project management tasks as assigned
  • Create and conduct training sessions including investigator meetings, conferences, and team trainings
  • Support the management and development of other CRAs
  • Train other CRAs during co-monitoring visits
  • Participate in the Clinical Operations community at Rho by leading key internal initiatives and standard operating procedures for the administration and monitoring the clinical trials.

Qualifications

Minimum Requirements

  •  7+ years of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry
  • BA/BS, preferably in a life science, nursing, pharmacy or related field
  • Broad range of therapeutic experience
  • Superior written and verbal communications skills
  • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
  • Demonstrated ability to train, mentor, and lead clinical research staff
  • The ability to constructively interact directly with sponsor personnel
  • This position requires up to 25% travel and is an office based role in Chapel Hill, NC.
  • Candidates must be willing to relocate to the Raleigh/Durham/Chapel Hill area and reside within a 1 hour commute distance of the office.

 

EOE. Veterans/Disabled