Reporting to the Clinical Project Manager, the Senior CRA will assist and provide support to the members of the clinical trial team in order to facilitate the clinical trial processes including execution of clinical trials. The Senior CRA is responsible for designing, implementing and maintaining clinical trials, and he/she will write protocols, case report forms and consent forms, recruit and select investigators and ensure good clinical practices are followed.
Duties and Responsibilities include the following
- Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
- Lead in designing, planning, and implementing complex clinical research projects.
- Oversee the design of study protocol, case report forms, informed consent to allow for accurate and thorough data collection to support the product through the approval process
- Review study records including case report forms, consent forms, and other materials.
- Support site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements
- Organize data in systematic manner to allow for efficient and accurate clinical reports
- Perform site visits to ensure regulatory and study requirements are being fulfilled
- Provide on-site support in the operating room or clinic during clinical study procedures
- Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols
- Assist in writing the clinical study report as well as the clinical portion of Regulatory submissions
- Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities
- Act as primary point of contact for sites and/or vendors
- Provide updates to project teams. Lead project related meetings
- Mentor junior team members
- Bachelor’s Degree in a Health or Science field, Master’s Degree preferred
- Minimum of 6 years of related experience
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
- Excellent organizational skills and attention to detail
- Some domestic and international travel would be required for site training, surgical cases coverage, monitoring responsibilities, and educational seminars
- Ability to travel approximately 35-50%