Clinical Trial Lead (All therapeutic Areas)
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Open Positions Available to be Filled ASAP!
The Clinical Team Lead role 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 operations 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.
Responsibilities will include but are not limited to:
· 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. 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
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. The Clinical Team Lead is required to travel 25% on average.
For further information about this role and to be considered as an applicant please get in touch with Jack Harvey at firstname.lastname@example.org or 919-838-7478