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Clinical Team Lead
at Rho, Inc.
- Regular Full-Time
The Clinical Team Lead is integral to driving project success. This position will function as the Lead CRA on select projects and will be responsible for providing direction to and training for 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.
- 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
- Develop 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)
- Monitor clinical operations timelines, metrics and activities
- Provide status updates to project management and sponsors
- Lead regular clinical team teleconferences
- Work effectively with Site Study Coordinators
- Participate in the RFP process, including internal and external business development meetings
- Review monitoring visit reports and ensure 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
- Travel up to 25%
- 7+ years of on-site monitoring experience within the CRO, pharmaceutical, or biotechnology industry, including at least 1 year in a lead position
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Broad range of therapeutic experience
- Superior written and verbal communication 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