Description
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the world’s leading oncology research organizations conducting community-based clinical trials. In 2022, SCRI formed a joint venture with former US Oncology Research to enhance clinical trial access and availability across the country. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. It has conducted more than 600 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. The combined research network brings together physicians who are actively accruing patients to clinical trials at more than 250 locations in 26 states across the US.
The Sr. CRA is an essential member of a Development Innovations project team responsible for the execution of a clinical research project. The degree of responsibility given to a Sr. CRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.
This position will focus on the on-site monitoring of Early Phase Oncology trials (Phase I-II).
Duties
- Serve as the primary point of contact for investigative sites.
- Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and region-specific requirements.
- Serve as a mentor within the organization, working with others to help them organize their time efficiently.
- Has in-depth knowledge of ICH/GCP and region-specific regulations and begins to give guidance to junior CRAs on applying this knowledge to the practice of monitoring.
- May perform CRA assessment and training visits per SOPs.
- Assist in the development and delivery of departmental trainings.
- Able to give practical guidance on application of systems, processes, and regulations.
- Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
60%-80% travel, including overnight stays, is required and may involve travel to meetings or attendance at conferences. In addition, weekend and evening travel may be required depending upon the workload and nature of current programs.
Qualification
- At least three years of CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites with experience in Phases l – ll.
- Have performed all visit types (PSV, SIV, RMV, and COV).
- Demonstrated leadership skills.
- Demonstrated successful high performance in CRA II competencies for candidates with less than 3 years of experience.
- Ability to travel 60%-80%.
Preferred Experience
- At least five years of CRA experience at a contract research organization (CRO) (OR) sponsor company monitoring clinical trials at investigative sites with direct oncology monitoring experience in Phase l – ll in solid and liquid tumor types.
- Have performed all visit types (PSV, SIV, RMV, and COV).
- Previous experience in a Sr. CRA role.
- Lead CRA experience.
