Senior Clinical Research Associate
New
R
Rakuten Medical Inc. - USBiotechnology
Remote; San Diego, California, United StatesFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum 3 years related industry experience with large company or 5 years with smaller company
- Required Skills
- GCP
Requirements
- Bachelor’s degree in life sciences or related field.
- Minimum 3 years industry experience with large company or 5 years with smaller company.
- Previous experience with oncology (head and neck cancer) preferred.
- Experience with combination drug-device studies preferred.
- Working knowledge of drug development process, GCP, ICH guidelines, and FDA regulations.
- Strong organizational and project management skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, MS Project) and Adobe Acrobat.
- Ability to work independently with minimal supervision.
- Ability and willingness to travel up to 60% nationally and internationally.
Responsibilities
- Conduct regular monitoring visits to ensure protocol compliance and subject safety.
- Perform Source Document Verification (SDV) for data accuracy.
- Maintain electronic and/or paper Trial Master File (TMF) documentation.
- Manage and oversee study-related vendors and CRO activities.
- Review vendor contracts, Statements of Work (SOWs), and invoices.
- Manage investigational products and review protocol deviations.
- Support training activities for clinical research teams and site staff.
- Provide on-site assistance and guidance to trial centers for execution of Photoimmunotherapy (PIT).
View Full Description & ApplyYou'll be redirected to the employer's site
