Clinical Trial Associate

工作描述
Clinical Studies
• Assist as require******** the start up of clinical trials includingsupport for investigator ******** investigator meet******** shipment ofstudy suppl******** collection of essential documents an******** forsite initiation
• Assist with routine communication to study sites an******** study team(Clinical Research Organizations (CROs) – other vendors – ProjectManagement Office Baxter - other). Support the CPM in development and/orimprovement of study specific procedures an********
• Maintain appropriate systems to ensure adequate an******** tracking ofstudy progress an******** production of require********.
• Maintain Clinical Trial Management System (CTMS) for theassigne******** in collaboration with CPM.
• Preparat******** collect******** process******** tracking an********of study-relate********, information an******** according to Goo********Practices an******** Operating Procedures
• Assist in preparation for internal an******** audits.
• Act as an internal support for CPM, handling any queries or issuesan******** that these are dealt with promptly by appropriate staff
• Develop an******** a basic working knowledge of relevant protocols
• Assist in the coordination of the assigne********/projects an********other project team duties as require******** delegate******** the CPM.

Regulatory documents
• Assist in reviewing regulatory documents for completeness an********Documentation Practices

Communication
• Internal an******** commun******** including meeting minutes
• Help organize clinical team meetings

职位要求
Comprehensive knowledge an******** of Goo******** Practices required.Ability to maintain effectiveness under changing circumstancesan********. Excellent verbal an******** communication an******** skillsrequired. Knowledge of computer software an******** attention to detailexpecte******** this position. Be a team player.


Education and/or Experience.
Preferably 2-3 years of clinical experience in pharmaceut********biotechnology or medical device company including CRO.