Senior Clinical Research Associate (RE-12451786) Sunnyvale, California
|Salary:||USD85 - USD100 per hour|
- Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
- Minimum of 4 to 6 years experience with monitoring In Vitro Diagnostic (IVD) products.
- Excellent knowledge of good clinical trial design
- Experience in all aspects of a clinical trial design including clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents (study protocol, monitoring plan, case report forms, etc.).
- Excellent oral and written communication skills.
- Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
- Knowledge of GCP & ICH guidelines and FDA regulations.
- Basic understanding of statistics.
- Must be able to develop strong rapport with investigators and site staff.
- Travel requirements of 20-40%.