Job Title: Clinical Trials Management Associate - III*
Location: Santa Monica, CA
Duration: 12+ Months
Specific Job Responsibilities:
Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas. With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required:
• Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines
• Assists in CRO or vendor selection
• With guidance from supervisor coordinates CROs or vendors
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
• Participate or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams (May participate in abstract presentations, oral presentations and manuscript development)
• Interfaces with individuals in other functional areas to address routine study issues
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives
• Travel is required
• Excellent verbal, written, interpersonal and presentation skills are required
• Working knowledge and experience with Word, PowerPoint and Excel
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
• Ability to develop tools and processes that increase measured efficiencies of the project
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.
Specific Education & Experience Requirements:
• 4+ years of experience and a BS or BA in a relevant scientific discipline
• 4+ years of experience and an RN (2 or 3 year certificate)
• CCRA or other certification desired
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