CONTRACT SCOPE OF WORK:
The individual contracted will provide transactional clinical monitoring subject expertise to sponsor’s Clinical Operations Team. Monitoring activities include but are not limited to conduct of site visits, verification of CRF data against required source documents; completion of visit reports and required sponsor trackers; scheduling site visits in compliance with monitoring plans; participation in project team calls; and interim site communication as specified by the sponsor. Additional services will include providing regular project status updates to Premier and sponsor Clinical Operations management.
Contractor will follow sponsor’s Standard Operating Procedures and ensure clinical study activities are conducted in accordance with all protocols, ICH-GCP/ISO14155, sponsor policies, and all applicable local laws and regulations.
Travel up to 75% and participation in sponsor required training programs.
The qualified contractor must possess a strong knowledge base of medical terminology, clinical pharmacology and pathophysiology; ability to communicate effectively with sponsor, site and Premier personnel at all levels; a high attention to detail; a Bachelors’ degree (BS, BA, or RN equivalent) in a biological- or science-related field is preferred; a minimum of three (3) to five (5) years of clinical experience in the pharmaceutical, biotechnology, device or CRO industry;working knowledge of ICH-GCP/ISO14155; and working knowledge of FDA, European Regulatory and EC procedures, as applicable.
Thsi project required gastroenterology and or hepatic therapeutic area experience.