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Clinical Trials Management Associate - II
Ref No.: 18-13319
Location: Foster City, California
Description:
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
• Must be able to understand, interpret and explain protocol requirements to others
• Maintains study timelines
• Coordinates review of data listings and preparation of interim/final clinical study reports
• Assists in determining the activities to support a study's priorities
• Contributes to development of RFPs and participates in selection of CROs/vendors
• May be asked to train CROs, vendors, investigators and study coordinators on study requirements
• Contributes to development of study budget
• May contribute to development of abstracts, presentations and manuscripts
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
• Excellent teamwork, communication, decision-making and organizational skills are required
• Thorough knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Excellent verbal and written communications skills
• Working knowledge and experience with Word, PowerPoint and Excel
• Strong problem solving skills
• May serve as a resource to more junior associates
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
• May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
• Assures site compliance with the protocol and regulatory requirements
• Manages vendors
• Mentors junior team members
• At least 3+ years of experience and a BS or BA in a relevant scientific discipline
Or
• At least 3+ years of experience and an RN (2 or 3 year certificate)