Danaher Corporation Clinical Research Associate I in Sunnyvale, California
Essential job responsibilities:
Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as the need arises.
Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits.
Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance.
Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor's degree in a scientific field (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
0-2 years related work experience
Knowledge and skills:
Excellent team skills and ability to prioritize and multi-task in a fast-paced environment.
Experience with Microsoft Office Applications, such as Word, Excel, PowerPoint etc.
Experience in the handling and shipping of Biohazardous specimens.
Knowledge of GCP & ICH guidelines and FDA regulations for clinical trials.
30-50% travel required
Preferred knowledge, skills and abilities:
Knowledge of and experience with In Vitro Diagnostic (IVD) products.
Ability to search clinical literature and be familiar with field of study and related areas.
Knowledge of conduct of clinical trials and with some in-house monitoring experience.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .