CRA Team Lead / Lead CRA (25% travel) - RTP, NC Office Based – Niche CRO
Our client, a rapidly expanding CRO in the RTP area, is actively recruiting for an experienced Clinical Team Leader to oversee all operational aspects for the planning and management of site performance for assigned projects. Duties will include providing direction and training to CRAs assigned to those projects, as well as independently managing and monitoring clinical trial sites and functioning as the Lead CRA on select projects.
This is a fast paced and busy setting, the company is seeking a natural point person, one who can drive the process forward from all angles. The select candidate will be responsible for ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.
Duties will include:
- Planning and managing the operational aspects of site performance to ensure productivity expectations are met
- Reviews and approves monitoring visit reports
- Drive the study start up process – track, report progress, review data
- Develop monitoring tools and plans and provides skilled review of study protocols and other study materials
- Monitors clinical operations timelines, metrics and activities
- Provides status updates to Sponsors and clinical teams
- Participate in the RFP process
- Support the management and development of other CRAs, to include training and co-monitoring
The ideal candidate will offer a BS or equivalent in a science discipline, plus 7+ years of solo field monitoring experience, including Lead CRA / Team Lead experience. CRO industry experience and a CRA background are required. Excellent communication skills combined with top notch problem solving and organizational skills are a must. The ability to multi-task and handle many moving parts will be a daily doing in this role.
This is a direct hire office based opportunity (no work from home) and the company is willing to pay top dollar (and provide relocation assistance) for the right candidate.
Please forward resume for prompt consideration.