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Clinical Trials Management Associate
3 weeks ago
Foster City, California, US

Job Description

? Must be familiar with routine medical/scientific terminology
? Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports
? May contribute to SOP development
? Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
? May monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
? May resolve routine monitoring issues
? Must be familiar with good documentation practices and electronic trial master file system
? Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
? Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
? 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
? May participate in abstract presentations, oral presentations and manuscript development.
? Interfaces with individuals in other functional areas to address routine study issues
? Ability to develop tools and processes that increase measured efficiencies of the project
? May be asked to assist in the training of CTMAs and CPAs
? Assists in CRO or vendor selection
? Coordinates CROs or vendors
? Assists in the setting and updating of study timelines
? May participate in departmental or interdepartmental strategic initiatives under general supervision
? Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies
? 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
? Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans
? Excellent verbal, written, interpersonal and presentation skills are required
? Knowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
? Working knowledge and experience with Word, PowerPoint and Excel

Job Requirements

Documentation, Compliance


Job Code: 50115453

Reach Out to a Recruiter

Recruiter Pooja
Phone +9738412451