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 the 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.
Proactively drive project success, including working closely with the 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
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 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
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 to the office
Internal Number: 2019-1453
About Rho, Inc.
Rho is a Contract Research Organization (CRO) with unsurpassed expertise, integrity, and passion for clinical research. Our dedication to providing outstanding clinical research is fueled by an unrivaled commitment to quality. Our distinct combination of expertise and insight delivers results in every phase of clinical research. We share the same level of involvement, commitment, and passion as our clients—a dedication to collaboration that delivers life-saving products with more efficiency and greater speed.