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Clinical Research Associate
Duties and Responsibilities
Leads development of site and study documentation such as training materials, reports, consent documents, study operation manuals, monitoring plans and regulatory submissions for the screening, initiation, conduct and reporting of clinical trials.
Leads preparation and maintenance of manuals, forms, tracking tools and reports for AE reporting, medical monitor review, CEC and DSMB conduct, as well as liaison with committees and members for scheduling and documentation.
Lead development of department SOPs and work instructions, support departmental planning.
Generates clinical data and status reports to support management, project team, study reports, regulatory submissions and publications.
Coordinates and prepares clinical study protocols with expert input (such as MD, statistical).
Supports investigational device administration including all documentation for forecasting, shipping, receiving, disposition, complaints, and returned goods.
Supports clinical data management in CRF development, validation rules and other reporting and analysis tasks, reimbursement for sites.
Communicates with team and department members.
Supports and maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information.
May support project teams for product development.
Support department activities as required.
Minimum Qualifications, Knowledge, Skills and Abilities
Working knowledge of and ability to follow US FDA regulations, ISO 14155, Good Clinical Practice and Japanese regulations.
Follows established SOPs and work instructions.
Experience in clinical research protocols, reporting, regulatory submissions, development of monitoring/analysis/data management plans with technical support.
Advanced knowledge of clinical research methods and practices for medical devices, including IDE and CE Mark studies.
Advanced auditing and self-auditing skills
Working project management and vendor management skills
Advanced clinical data monitoring skills: paper and EMR
Excellent/advanced oral and written communications skills
Proficient computer skills including word processing, spreadsheet generation and database querying and reporting skills.
Ability to be point of contact for investigators and site staff on a clinical trial.
Demonstrable skills in organizational and project administration skills, tracking study activities for timeliness and completeness.
BS degree in life science, nursing or equivalent
8+ years directly related work experience or equivalent
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