Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
Assist in implementing clinical research projects
Review case report forms and informed consent forms against the study protocol and other governing documents to allow for accurate and thorough data collection to support the product through the regulatory approval process
Assist 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 joint site visits with other CRAs to ensure regulatory and study requirements are being fulfilled

Bachelor's degree in a scientific or health care discipline preferred and /or training; or equivalent combination of education and experience.
2+ years' recent experience in clinical role
Excellent verbal and written communication skills
Excellent organizational skills along with strong attention to detail
Ability to work both independently and collaboratively with cross-functional teams
Highly proficient with Microsoft Office Suite
Ability to travel approximately 35-40%

Clinical Research Associate

Key skills