Clinical Data Coordinator
Location: San Diego, CA
Duration: 6 Months
The Clinical Data Coordinator provides critical study conduct support through the basic clinical data reviews, query generation, reconciliation and reporting. Additional responsibilities include supporting clinical study team members in the completion and filing (paper and electronic) of clinical data, reports and administrative study documentation.
• Conducts basic clinical data review, query generation/resolution to support clinical study team activities according to SOP/WI and Data Management Plans.
• Assist with data reconciliation, e.g. core labs, central labs, images, FM data, inventory administration
• Support CRF development, database development, and testing on new studies
• Support maintenance, distribution and tracking of study status reports to clinical study teams, project teams, investigational sites and other stakeholders
• Support generation, distribution and tracking of clinical data reports to support management, project team, biostatistics, study reports, regulatory submissions and publications
• Trial Master File and Index maintenance - Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information (paper and/or electronic)
• Supports and maintains investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned good
• Supports site and vendor payment administration including study payments, PO maintenance, monthly reports for finance.
• Support assembly and distribution of department and study communications such at reports, newsletters and mass communications.
• Support department activities as required.
MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:
• Follows established SOPs and work instructions.
• Proficient computer skills including word processing, spreadsheet generation and database querying and reporting skills.
• Good self-auditing skills and attention to detail
• Good oral and written communications skills (English)
• Ability to be point of contact for Clinical Research Associates for data related inquiries and data reporting.
• Organizational and project administration skills, tracking study activities for timeliness and completeness across multiple studies.
• BS degree in science or life science preferred
• 2+ years in related healthcare work experience or equivalent
• General understanding of US FDA regulations, ISO 14155, Good Clinical Practice and Japanese regulations.
• Experience in clinical database work and/or regulated environment