Job Description
Description
Job Responsibilities
Contribute during new product development and study documentation of the assigned studies. Apply and comply with clinical procedures for Good Clinical Practice (GCP) and all applicable regulations for sponsored studies conducted at participating sites.
Manage the overall process for the conduct of the program sponsored R&D External Analytical or Clinical/ Performance study protocols.
Prepare and/or review documents for submission/ essential study start-up as they relate to the assigned clinical/ performance evaluation studies (Clinical/ Performance study protocols, Informed Consent form, Investigator Brochure, Monitoring Plan, Laboratory Manual, Clinical Site Procedures, Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents) in accordance with GPC, and applicable international and regional/ country practices for privacy and protection of human subjects.